Method of using ultrasonic vibration to secure body tissue

ABSTRACT

A suture and a suture retainer are positioned relative to body tissue. Ultrasonic vibratory energy is utilized to heat the suture retainer and effect a bonding of portions of the suture retainer to each other and/or to the suture. Portions of the body tissue may be pressed into linear apposition with each other and held in place by cooperation between the suture and the suture retainer. The suture retainer may include one or more portions between which the suture extends. The suture retainer may include sections which have surface areas which are bonded together. If desired, the suture may be wrapped around one of the sections of the suture retainer. The suture retainer may be formed with a recess in which the suture is received. If desired, the suture retainer may be omitted and the sections of the suture bonded to each other.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.10/458,117, filed Jun. 10, 2003, now U.S. Pat. No. 7,429,266 which is adivisional of U.S. patent application Ser. No. 10/076,919, filed Feb.15, 2002, now U.S. Pat. No. 6,585,750, which is a divisional of U.S.patent application Ser. No. 09/524,397, filed Mar. 13, 2000, now U.S.Pat. No. 6,368,343.

FIELD OF THE INVENTION

The present invention relates to a new and improved method of securingbody tissue by using ultrasonic vibratory energy.

BACKGROUND OF THE INVENTION

Difficulty has been encountered in securing sutures against movementrelative to body tissue. A knot may be tied in a suture to preventloosening of the suture. However, the knot weakens a portion of thesuture and reduces the overall force transmitting capability of thesuture. It has been suggested that a suture could be secured using asuture retainer in the manner disclosed in U.S. Pat. Nos. 5,735,875 and6,010,525.

When a suture retainer is used to maintain a suture in a desiredposition relative to body tissue, the material of the suture retainermay be pressed against the suture. During pressing of the material ofthe retainer against the suture, the suture may be heated to promote aflowing of the material of the suture retainer and bonding to thematerial of the suture retainer to the surface of the suture by heatingmaterial of the suture retainer into its transition temperature range.

When the material of the suture retainer is heated into its transitiontemperature range, the material changes from a solid condition in whichit has a fixed form to a soft or viscous condition. When the material ofa suture retainer has been heated into the transition temperature range,the material can be molded around an outer side surface of a suture andbonded to the suture without significant deformation of the suture. Thetransition temperature ranges for various polymers which are suitablefor forming suture retainers are disclosed in the aforementioned U.S.Pat. No. 5,735,875.

SUMMARY OF THE INVENTION

The present invention provides a new and improved method for use insecuring body tissue. If desired, a suture retainer may be used to gripthe suture. When a suture retainer is used, ultrasonic vibratory energyis transmitted to the material of the suture retainer to effect aheating of at least some of the material of the suture retainer.Portions of the suture retainer are then bonded to each other and/or tothe suture.

It may be desired to retain layers of body tissue in linear appositionwith each other. When this is to be done, a suture is used to hold thelayers of body tissue in linear apposition after they have beenapproximated to each other. The suture may be secured relative to thebody tissue by a suture retainer or crimp. Alternatively, sections ofthe suture may be secured together. To secure the suture relative to thebody tissue, ultrasonic vibratory energy is applied to either the sutureor the suture retainer. The ultrasonic energy may be applied while thesuture is being tensioned with a predetermined force and while apredetermined force is being transmitted to the body tissue.

The suture retainer or crimp may have any one of many differentconstructions. One specific suture retainer constructed in accordancewith one of the features of the present invention includes one or morepassages through which one or more sections of the suture are inserted.In another embodiment of the invention, the suture retainer has sectionswhich are formed separately from each other. The sections of the sutureretainer are connected with the suture and/or each other by transmittingultrasonic vibratory energy to at least one of the sections of thesuture.

If desired, the suture may be wrapped around a portion of the sutureretainer. The suture retainer may be provided with one or more recessesinto which one or more sections of the suture are moved. Thetransmission of ultrasonic vibratory energy to the suture retainer isutilized to effect a bonding of portions of the suture retainer witheach other and/or with the suture.

The suture retainer may be omitted and sections of the suture bonded toeach other. When this is to be done, ultrasonic vibratory energy istransmitted to the sections of the suture. Force is applied againstopposite sides of the sections of the suture to increase the extent ofthe sections of the suture in a direction transverse to the sections ofthe suture. As the transverse extent of the suture is increased, areason outer side surfaces of the sections of the suture are increased.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing and other features of the invention will become moreapparent upon a consideration of the following description taken inconnection with the accompanying drawings wherein:

FIG. 1 is a schematic illustration depicting the manner in which layersof body tissue are moved into linear apposition with each other andsecured with a suture and suture retainer;

FIG. 2 is a schematic fragmentary sectional view illustrating the mannerin which the suture and suture retainer of FIG. 1 are positionedrelative to each other;

FIG. 3 is a fragmentary schematic illustration depicting the manner inwhich ultrasonic vibratory energy is applied to the suture retainer ofFIG. 2;

FIG. 4 is a schematic fragmentary sectional view of another embodimentof the invention and illustrating the approximation of layers of tissueby tensioning a suture with a predetermined force and pressing a sutureretainer against the body tissue with a predetermined force;

FIG. 5 is a schematic fragmentary sectional view of another embodimentof the invention and illustrating the manner in a vibration applicatormember engages a suture retainer which is being pressed against bodytissue with a predetermined force while an associated suture istensioned with a predetermined force;

FIG. 6 is a schematic fragmentary pictorial illustration of anotherembodiment of the invention and depicting the construction of sectionsof a suture retainer and the relationship of the sections of the sutureretainer to apparatus for applying ultrasonic vibratory energy to thesuture retainer;

FIG. 7 is a schematic pictorial illustration of an embodiment of theinvention in which a suture retainer has a pair of passages forreceiving sections of a suture;

FIG. 8 is a schematic illustration depicting the manner in whichultrasonic vibratory energy is applied to the suture retainer of FIG. 7;

FIG. 9 is an exploded fragmentary schematic illustration of anotherembodiment of the invention and depicting the manner in which a sutureis wrapped around a section of a suture retainer and the relationship ofapparatus for applying ultrasonic vibratory energy to sections of thesuture retainer;

FIG. 10 is a schematic pictorial illustration of another embodiment ofthe invention and depicting the manner in which sections of a sutureextend through passages in a section of a suture retainer;

FIG. 11 is a schematic fragmentary sectional view depicting therelationship of the section of the suture retainer illustrated in FIG.10 to other sections of the suture retainer and to an apparatus forapplying ultrasonic vibratory energy to the suture retainer;

FIG. 12 is a schematic illustration of another embodiment of theinvention and depicting the relationship between sections of a sutureand sections of a suture retainer;

FIG. 13 is a top plan view, taken generally along the line 13-13 of FIG.12, illustrating the relationship of the sections of the suture retainerand suture to an apparatus for applying ultrasonic vibratory energy tothe suture retainer;

FIG. 14 is a schematic illustration of another embodiment of theinvention and depicting the manner in which sections of a suture arewrapped around a section of a suture retainer;

FIG. 15 is a schematic sectional view, taken generally along the line15-15 of FIG. 14, illustrating the relationship between sections of thesuture retainer and an apparatus for applying ultrasonic vibratoryenergy to the suture retainer;

FIG. 16 is a schematic plan view of another embodiment of the invention,illustrating the relationship of sections of a suture to recesses formedin a suture retainer which is disposed between portions of an apparatusfor applying ultrasonic vibratory energy to the suture retainer;

FIG. 17 is an enlarged fragmentary schematic illustration depicting themanner in which a section of the suture is moved into one of therecesses in the suture retainer of FIG. 16;

FIG. 18 is a schematic pictorial illustration depicting the manner inwhich another embodiment of the suture retainer is positioned relativeto the suture;

FIG. 19 is a plan view, taken generally along the line 19-19 of FIG. 18,illustrating the relationship between the suture retainer and thesuture;

FIG. 20 is a plan view, generally similar to FIG. 19, illustrating therelationship of an apparatus for applying ultrasonic vibratory energy tothe suture retainer and the suture retainer and suture of FIG. 19;

FIG. 21 is a schematic pictorial illustration of an embodiment of thesuture retainer having a recess which receives a portion of a suture;

FIG. 22 is a plan view of another embodiment of the invention andillustrating the manner in which a suture is positioned in a recess inthe suture retainer and the relationship of apparatus for applyingultrasonic vibratory energy to the suture retainer;

FIG. 23 is a schematic illustration of another embodiment of theinvention and depicting the manner in which a suture and a sutureretainer are utilized to hold layers of body tissue in apposition witheach other;

FIG. 24 is a schematic illustration of one apparatus for applyingultrasonic vibratory energy to a suture retainer;

FIG. 25 is a schematic illustration of a second apparatus for applyingultrasonic vibratory energy to a suture retainer;

FIG. 26 is a schematic illustration, similar to FIG. 1, depicting themanner in which layers of body tissue are moved into linear appositionwith each other and secured with a suture;

FIG. 27 is a schematic fragmentary sectional view illustrating themanner in which sections of the suture of FIG. 26 are positionedrelative to each other and to apparatus which applies ultrasonicvibratory energy to the sections of the suture; and

FIG. 28 is a schematic illustration depicting the manner in whichsections of the suture of FIG. 27 are extended.

DETAILED DESCRIPTION OF THE INVENTION Embodiment of FIGS. 1-3

A tissue securing system 30 (FIG. 1) includes a suture 32 and a sutureretainer or crimp 34. The suture 32 includes left and right sections 38and 40 which are interconnected by a connector section 42. The sutureretainer 34 grips the left and right sections 38 and 40 of the suture32.

The tissue securing system 30 is used in a sterile, operating roomenvironment to secure upper and lower layers 46 and 48 of soft, humanbody tissue in linear apposition with each other. Thus, the two layers46 and 48 of human body tissue are approximated and held againstmovement relative to each other by the suture 32. Although the twolayers 46 and 48 of body tissue have been schematically illustrated inFIG. 1 as being spaced apart from each other, they are held in aside-by-side relationship with each other and pressed together bytightening the tissue securing system 30. Pressing the two layers 46 and48 together with the tissue securing system 30 promotes healing of thetissue.

Although the tissue securing system 30 has been illustrated in FIG. 1 asbeing used to hold layers of soft tissue in linear apposition with eachother, it is contemplated that the tissue securing system may be used inmany different locations in a patient's body to secure tissue. Forexample, the tissue securing system 30 could be utilized to secure softtissue, such as a ligament or tendon, against movement relative to abone. Alternatively, the tissue securing system 30 could be utilized tointerconnect portions of a flexible conduit, such as a blood vessel orintestine. It should be understood that the tissue securing system 30may be used with either hard body tissue, or soft body tissue, or bothhard and soft body tissue.

If desired, a force distribution member, such as a button, could beutilized between the connector section 42 of the suture 32 and the lowerlayer 48 of body tissue. The force distribution member would distributeforce over a relative large area of the lower layer 48 of body tissue.Similarly, a force distribution member, such as a button, could beutilized between the upper layer 46 of soft tissue and the left andright sections 38 and 40 of the suture 32 and the suture retainer 34.

It is also contemplated that the suture 32 could extend through a sutureanchor and/or be connected with body tissue in a manner similar to thatdisclosed in U.S. Pat. Nos. 5,584,862; 5,549,631; and/or 5,527,343. Ofcourse, the suture 32 could be connected with body tissue in a differentmanner if desired. For example, the connector section 42 could beeliminated. If this is done, the left section 38 of the suture 32 couldbe connected with one suture anchor and the right section 40 of thesuture could be connected with a second suture anchor.

Although the sections 38 and 40 of the suture 32 could extend straightthrough the suture retainer 34, in the illustrated embodiment of theinvention, the sections 38 and 40 of the suture 32 are wrapped aroundportions of the suture retainer 34. Thus, the left section 38 of thesuture 32 is wrapped around a portion 52 (FIG. 2) of the suture retainer34. Similarly, the right section 40 of the suture is wrapped around aportion 54 of the suture retainer 34.

In the illustrated embodiment of the invention, the left section 38 ofthe suture 32 is wrapped for more than a complete turn around theportion 52 of the suture retainer and the right section 40 of the sutureis wrapped for more than a complete turn around the portion 54 of thesuture retainer. However, if desired, wrapping of the sections 38 and 40of the suture 32 around the suture retainer 34 could be omitted or eachof the sections of the suture could be wrapped for less than onecomplete turn around a portion of the suture retainer.

When the sections 38 and 40 of the suture 32 are wrapped around theportions 52 and 54 of the suture retainer 34, a plurality of bends areformed in each of the sections of the suture. Thus, bends 58, 60, 62 and64 are formed in the section 38 of the suture 32 as it is wrapped aroundthe portion 52 of the suture retainer 34. Similarly, bends 66, 68, 70and 72 are formed in the section 40 of the suture 32 as it is wrappedaround the portion 54 of the suture retainer 34. Of course, a greaternumber of bends would be formed in each of the sections 38 and 40 of thesuture 32 if they were wrapped a greater number of times around thesuture retainer 34.

Although the suture retainer 34 could have many different constructionsand configurations, in the illustrated embodiment of the invention, thesuture retainer 34 is integrally formed as one piece and has a sphericalconfiguration. A cylindrical central passage 76 extends axially throughthe suture retainer 34 between upper and lower (as viewed in FIG. 2)polar regions of the spherical suture retainer. The two sections 38 and40 of the suture 32 extend through the passage 76. The suture retainer34 is formed separately from the suture 32 and is initially disconnectedfrom the suture.

In the illustrated embodiment of the invention, two lengths of the leftsuture section 38 and two lengths of the right suture section 40 extendthrough the passage 76 as a result of the wrapping of the sections ofthe suture around the portions 52 and 54 of the suture retainer 34.However, the two sections 38 and 40 of the suture 32 could extendstraight through the passage 76 without being wrapped around theportions 52 and 54 of the suture retainer 34. If this was done, only asingle length of the left section 38 of the suture 32 would be disposedin the passage 76 adjacent to a single length of the right section 40 ofthe suture 32. Of course, if the sections 38 and 40 of the suture 32were wrapped around the portions 52 and 54 of the suture retainer for agreater number of turns, a greater number of lengths of the sections 38and 40 of the suture 32 would extend through the passage 76.

In the illustrated embodiment of the suture retainer 34, a pair ofgrooves or recesses 80 and 82 extend radially inward from a sphericalouter side surface 84 of the suture retainer 34. The grooves or recesses80 and 82 are relatively deep so that the portions 52 and 54 of thesuture retainer around which the suture is wrapped are relativelyslender. This results in relatively short lengths of the sections 38 and40 of the suture being disposed in engagement with the outer sidesurface of the suture retainer 34 adjacent to the upper and lower polarregions of the suture retainer.

In the embodiment of the invention illustrated in FIG. 2, the grooves orrecesses 80 and 82 extend inward from the outer side surface 84 of thesuture retainer 34. The depth of the grooves or recesses 80 and 82varies along the vertical (as viewed in FIG. 2) length of the grooves.However, it is contemplated that the grooves 80 and 82 could beconstructed so as to have a uniform depth throughout their length. Ifthis was done, the grooves 80 and 82 would have an arcuate configurationwith centers of curvature which are coincident with the center ofcurvature of the spherical outer side surface 84 of the suture retainer34.

Rather than opening radially outward to the outer side surface 84 of thesuture retainer 34, the grooves 80 and 82 could be undercut to enclosethe portions of the suture 32 disposed in the grooves. It iscontemplated that the grooves could have any one of the grooveconfigurations disclosed in U.S. Pat. No. 6,010,525. The disclosure fromthe aforementioned U.S. Pat. No. 6,010,525 is incorporated herein in itsentirety by this reference thereto. Alternatively, the grooves 80 and 82could be formed as passages which extend through the suture retainer 34parallel to and spaced apart from the central passage 76.

It is contemplated that the suture retainer 34 may be formed of manydifferent materials. However, it is contemplated that it will bepreferred to form the suture retainer 34 of a biodegradable polymer. Onebiodegradable polymer which may be utilized is polycaperlactone.Alternatively, the suture retainer 34 could be formed of polyethyleneoxide terephthalate or polybutylene terephthalate. The suture retainer34 could be formed as a polyhydroxyalkanoate if desired. It is alsocontemplated that other biodegradable or other bioerodible copolymerscould be utilized if desired.

Although it is preferred to form the suture retainer 34 of abiodegradable material, the suture retainer could be formed of amaterial which is not biodegradable. For example, the suture retainer 34could be formed of an acetyl resin, such as “Delrin” (trademark).Alternatively, the suture retainer 34 could be formed of apara-dimethylamino-benzenediazo sodium sulfonate, such as “Dexon”(trademark). If desired, the suture retainer 34 could be formed ofnylon.

The suture 32 may be formed of the same material as the suture retainer34 or of a different material. The suture 32 may be formed of natural orsynthetic materials. The suture 32 may be a monofilament or may beformed of a plurality of interconnected filaments. The suture 32 may bebiodegradable or non-biodegradable. It is contemplated that the sutureretainer 34 could be utilized in association with force transmittingelements other than a suture. It is believed that it may be preferred toform the suture 32 of the same material as the suture retainer 34.

In accordance with a feature of the present invention, ultrasonicvibratory energy is utilized to cause the suture retainer 34 to grip thesuture 32. The ultrasonic vibratory energy is at a frequency above thatwhich can normally be detected by the human ear, that is, above 16 to 20kilohertz. Although there are a wide range of frequencies which may beutilized, it is believed that it will be desirable to use ultrasonicenergy having a frequency of between 20 kilohertz and 70 kilohertz.However, higher frequency vibratory energy could be utilized if desired.

The ultrasonic vibratory energy may be continuously applied, pulsed ormodulated in various fashions. Any one of many known transducers may beutilized to change electrical energy into mechanical vibrations havingan ultrasonic frequency. The transducers may be piezoelectric,ferroelectric, or magnetostrictive. One commercial source of apparatuswhich may be utilized to provide ultrasonic vibratory energy is DukaneCorporation, Ultrasonics Division, 2900 Dukane Drive, St. Charles, Ill.Of course, there are other sources of apparatus which can be utilized toprovide ultrasonic vibratory energy.

The ultrasonic vibratory energy creates frictional heat at the areaswhere the suture retainer 34 and suture 32 are disposed in engagementwith each other. The frictional heat provided by the ultrasonicvibratory energy is effective to heat the material of the sutureretainer 34 into its transition temperature range while the material ofthe suture 32 remains at a temperature close to or below its transitiontemperature range. For example, the suture 32 may be formed of amaterial having a transition temperature range which is above 190degrees Celsius. The suture retainer 34 may have a transitiontemperature range which, for the most part, is at a temperature below190 degrees Celsius.

However, it should be understood that at least a portion or even theentire transition temperature range for the suture 32 could beco-extensive with the transition range for the suture retainer 34. Infact, the transition temperature range of the suture 32 could extendbelow the transition temperature range of the suture retainer 34.However, it is believed that it may be preferred to have the transitiontemperature range for the suture 32 above at least a portion of thetransition temperature range of the suture retainer 34.

Once the material of the suture retainer 34 has been heated into itstransition temperature range by the ultrasonic vibratory energy, theplastic material of the suture retainer 34 loses its rigidity andbecomes soft and viscous. The softened material of the suture retaineris moldable and flows, when subjected to pressure, around the suture 32without significant deformation of the suture. However, the temperaturerange into which the suture 32 is heated and the pressure appliedagainst the suture may result in some deformation of the suture.

Although it is contemplated that the suture 32 and suture retainer 34could be made of many different materials, the suture and sutureretainer may be formed of a plastic material which is a biopolymer. Forexample, the suture 32 and/or suture retainer 34 may be formed ofpolyglycolide which is commercial available under the trademark “Dexon”.Polyglycolide is a crystalline material that melts at about 225°Celsius. However, the suture could be formed of a glycolide-basedcopolymer which is commercially available under the trademark “Vicryl”.

The suture retainer 34 is also made of a plastic material which may be abiopolymer. For example, the suture retainer 34 may be made ofpolydellactide. The transition temperature of polydellactide will varydepending upon the specific characteristics of the material. However, asuture retainer 34 formed of polydellactide may have a transitiontemperature range of about 75° Celsius to about 120° Celsius. Othermaterials which may be utilized for forming the suture 32 and/or sutureretainer 34 are disclosed in U.S. Pat. No. 5,735,875. The disclosure inthe aforementioned U.S. Pat. No. 5,735,875 is hereby incorporated hereinin its entirety by this reference thereto.

In order to promote bonding of the material of the suture retainer 34 tothe suture 32, both the suture and suture retainer may be formed of thesame amorphous thermoplastic material. For example, both the suture 32and suture retainer 34 may be formed of a polyhydroxy-alkanoate.Alternatively, both the suture 32 and suture retainer 34 may be formedof nylon. It is contemplated that the suture 32 and suture retainer 34could be formed of different amorphous polymers which are similar, thatis, have the same or similar chemical properties.

When the ultrasonic vibratory energy is to be applied to the sutureretainer 34, a supportive member or anvil 90 (FIG. 3) is positioned inengagement with one side of the suture retainer 34. A horn or acoustictool 92 is positioned in engagement with the opposite side of the sutureretainer 34. Force, indicated schematically by arrows 96 and 98 in FIG.3, is applied against the suture retainer 34 by the anvil 90 and horn92.

The horn is vibrated, horizontally as viewed in FIG. 3, at a rate inexcess of 20 kilohertz. Although the horn 92 may be vibrated at anydesired frequency within range of 20 kilohertz to 70 kilohertz, it isbelieved that it may be desirable to vibrate the horn 92 at a rate whichis close to or greater than 70 kilohertz. The horn 92 is vibrated for adwell time which is sufficient to transmit enough ultrasonic vibratoryenergy to the suture retainer 34 to heat at least a portion of thematerial of the suture retainer 34 into its transition temperaturerange.

To effect a heating of the material of the suture retainer 34,mechanical vibrations are transmitted from the horn 92 through thematerial of the retainer 34 to a location adjacent to an interfacebetween the suture 32 and the suture retainer 34. The frictional heatcreated by the ultrasonic vibratory energy transmitted to the sutureretainer from the horn 92 is sufficient to heat the material of thesuture retainer 34 at locations adjacent to the suture 32, into thetransition temperature range of the material of the suture retainer. Asthis occurs, the passage 76 and grooves 80 and 82 collapse under theinfluence of the force indicated at 96 and 98 in FIG. 3 and theultrasonic vibratory energy transmitted from the horn 92.

The vibration of the horn 92 is then interrupted and the material of thesuture retainer 34 begins to cool. The clamping force, indicated by thearrows 96 and 98, is maintained against opposite sides of the sutureretainer 34 by the anvil 90 and horn 92 during the time which ultrasonicvibratory energy is transmitted from the horn 92 to the material of thesuture retainer 34. After interruption of the transmission of ultrasonicvibratory energy, the clamping force, indicated schematically by thearrows 96 and 98 and applied by the anvil 90 and horn 92, is maintainedfor a predetermined amount of time sufficient to allow the material ofthe suture retainer to cool and bond to both itself and the suture 32.

If desired, the force, indicated schematically by the arrows 96 and 98in FIG. 3, applied by the anvil 90 and horn 92 to the suture retainer 34may be increased as the transmission of ultrasonic vibratory energy tothe suture retainer 34 from the horn 92 is interrupted. The force,indicated schematically by the arrows 96 and 98 in FIG. 3, is sufficientto cause the passage 76 and recesses 80 and 82 to collapse as the sutureretainer 34 is heated by ultrasonic vibratory energy and subsequentlyallowed to cool.

The length of time for which ultrasonic vibratory energy is transmittedto the suture retainer 34 may vary as a function of the amplitude andfrequency of the ultrasonic vibratory energy transmitted to the sutureretainer. It is contemplated that the frequency of the ultrasonicvibratory energy will be in a range of between 20 kilohertz and 70kilohertz. It is contemplated that the amplitude of the ultrasonicvibrations may vary within a range of 0.0008 inches to 0.0050 inchesdepending upon the design of the suture retainer 34 and the materialforming the suture retainer.

It is also contemplated that the force, indicated schematically by thearrows 96 and 98, applied against the suture retainer 34 may varydepending upon the construction of the suture retainer 34 and thematerial forming the suture retainer. For example, a force ofapproximately 1-15 pounds may be applied against the suture retainer 34by both the anvil 90 and horn 92. However, the amount of force which isapplied will probably be different for different suture retainers anddifferent horns 92.

It is believed that the ultrasonic vibratory energy may be transmittedfrom the horn 92 to the suture retainer 34 for a period of time whichvaries between 0.25 seconds and 1.0 second. After the transmission ofultrasonic vibratory energy has been interrupted, the force, indicatedby the arrows 96 and 98, may continue to be applied to the sutureretainer 34 by the anvil 90 and horn 92 for approximately 1.0 seconds.

The extent to which the suture retainer 34 is compressed by the force 96and 98 applied against the suture retainer by the anvil 90 and horn 92has been illustrated schematically in FIG. 3. It is contemplated thatthe distance through which the anvil 90 and horn 92 move toward eachother to compress the suture retainer 34 may be from 0.010 inches to0.050 inches. Of course, the distance through which the suture retainer34 is compressed by the anvil 90 and horn 92 may be different for sutureretainers having different constructions and/or formed of differentmaterials.

It should be understood that the foregoing specific operatingcharacteristics, for example, amplitude and frequency of the ultrasonicvibratory energy transmitted from the horn 92 to the suture retainer 34,force applied against the suture retainer by the anvil 90 and horn 92,time for which force and/or ultrasonic vibratory energy is applied, andthe distance through which the suture retainer is compressed, have beenset forth herein for purposes of clarity of description. It iscontemplated that the foregoing specific numerical values will bedifferent for different embodiments of the invention and may varyextensively from the exemplary values set forth.

When the two layers 46 and 48 of body tissue are to be held in positionrelative to each other by the tissue securing system 30, the suture 32is positioned relative to the layers of body tissue. The left and rightsections 38 and 40 of the suture 32 extend through the two layers 46 and48 of tissue. Although the sections 38 and 40 of the suture 32 have beenillustrated schematically in FIG. 1 as extending through passages in thelayers 46 and 48 of body tissue, the passages could be omitted and thesuture 32 sewn through the body tissue without forming passages in thebody tissue.

In the embodiment of the invention illustrated in FIG. 1, the sections38 and 40 of the suture 32 are interconnected by the connector section42 which extends along one side of the layer 48 of body tissue. Ifdesired, the sections 38 and 40 of the suture 32 could be connected witha single anchor embedded in either hard or soft body tissue.Alternatively, a separate anchor could be provided for each of thesections 38 and 40 of the suture 32. These anchors could be embedded inthe body tissue or disposed adjacent to one side of the body tissue.

When the suture 32 has been positioned relative to the two layers 46 and48 of body tissue, the two layers of body tissue are pressed againsteach other in linear apposition. The suture retainer 34 is thenconnected with the suture 32. When the suture retainer 34 is to beconnected with the suture 32, the left (as viewed in FIG. 2) section 38of the suture is inserted through the central passage 76 in the sutureretainer 34. The left section 38 of the suture 32 is then wrapped aroundthe portion 52 of the suture retainer 34 and again inserted through thecentral passage 76.

Similarly, the right section 40 of the suture 32 is inserted through thecentral passage 76 and wrapped around the portion 54 of the sutureretainer 34. The right section 40 of the suture is then inserted throughthe central passage 76 for a second time. This results in the suture 32being connected with the suture retainer 34 in the manner illustratedschematically in FIG. 2.

The suture retainer 34 is then moved downward (as viewed in FIGS. 1 and2) along the suture 32 toward the upper layer 46 of body tissue. Thesuture 32 is tensioned with a predetermined force during downwardmovement of the suture retainer 34 toward the body tissue. As the sutureretainer 34 moves downward (as viewed in FIGS. 1 and 2) along the suture32 toward the upper layer 46 of body tissue, the turns formed in thesections of the suture around the portions 52 and 54 of the sutureretainer 34 move downward toward the body tissue. Thus, the bends 58-64in the section 38 of the suture 32 and the bends 66-72 in the section 40of the suture 32 move along the suture toward the upper layer 46 of bodytissue with the suture retainer 34.

As the suture retainer 34 is moved along the suture 32 toward the upperlayer 46 of body tissue, a predetermined tension, indicated by arrows102 and 104 in FIG. 3, is maintained in the sections 38 and 40 of thesuture 32. The magnitude of the tension forces 102 and 104 in thesections 38 and 40 of the suture 32 is selected as a function of thecharacteristics of the layers 46 and 48 of body tissue and as a functionof the strength of the suture.

As the suture retainer 34 moves downward (as viewed in FIGS. 1-3), theleading portion of the suture retainer moves into engagement with theupper layer 46 of body tissue (FIG. 3). The suture retainer 34 is thenpressed against the upper layer 46 of body tissue. If desired, a forcedistribution member, such as a button, could be provided between thesuture retainer 34 and the body tissue 46.

The suture retainer 34 is pressed downward against the body tissue 46with a predetermined force, indicated schematically by an arrow 106 inFIG. 3, while a predetermined tension, indicated schematically by thearrows 102 and 104, is maintained in the suture 32. The forcetransmitted from the suture 32 and suture retainer 34 to the layers 46and 48 of body tissue presses them together and, to some extent,compresses the layers of body tissue. This results in the layers of bodytissue being held in linear apposition and being compressed to promotehealing of the layers 46 and 48 of body tissue.

The force, indicated by the arrows 102 and 104, with which the sections38 and 40 of the suture 32 are tensioned, may vary depending upon thematerial from which the suture is constructed and the size of thesuture. By consulting a chart, a surgeon can select a suture size andstrength suitable for a particular use. Thus, a relatively large suturehaving substantial strength may be selected when body tissue is to beconnected with a bone or when portions of a bone are to beinterconnected by the suture. On the other hand, a relatively smallsuture size having a relatively small strength may be selected whendelicate body tissue, such as stomach or intestinal tissue, is to beinterconnected with the suture. The tension forces 102 and 104 in thesections 38 and 40 are determined as a function of the strength 32 ofthe suture and the characteristics of the body tissue through which thesuture extends.

The suture 34 is pressed against the body tissue with a force which isalso a function of the size and strength of the suture 32 and thecharacteristics of the body tissue 46 and 48. One way in which forcewith which the suture 32 is tensioned and with which the suture 34 ispressed against body tissue is disclosed in U.S. patent application Ser.No. 09/348,940 filed Jul. 7, 1999 by Peter M. Bonutti et al. andentitled “Method and Apparatus for Securing a Suture”. The disclosure inthe aforementioned U.S. patent application Ser. No. 09/348,940 is herebyincorporated herein by this reference thereto.

After the suture retainer 34 has been pressed against the body tissuewith a predetermined force and the suture 32 tensioned with apredetermined force to compress the layers 46 and 48 of body tissue,ultrasonic vibratory energy is applied to the suture retainer. To applythe ultrasonic vibratory energy to the suture retainer 34, the anvil 90(FIG. 3) is positioned in engagement with one side of the sutureretainer and the horn 92 is positioned in engagement with the oppositeside of the suture retainer. The anvil 90 and horn 92 are urged towardeach other with a predetermined force, indicated schematically by thearrows 96 and 98 in FIG. 3.

The specific magnitude of the force 96 and 98 will vary depending uponthe composition of the suture retainer 34 and the construction of thesuture retainer. In addition, the magnitude of the force 96 and 98 willvary as a function of the desired extent of deformation of the sutureretainer 34. When the suture retainer 34 has been heat softened byultrasonic vibratory energy, the material of the suture retainer ispliable and is plastically deformed by the force applied against thesuture retainer by the anvil 90 and horn 92.

In addition to the anvil 90 and horn 92, the apparatus for transmittingultrasonic vibratory energy to the suture retainer 34 includes agenerator (not shown) which changes standard electrical power intoelectrical energy at the desired ultrasonic frequency. A transducer (notshown) changes the electrical energy into low amplitude mechanicalmotion or vibration. These vibrations are transmitted to a booster whichis used to increase or decrease the amplitude of the vibrations. Thevibrations are then transmitted to the horn 92.

The ultrasonic vibratory energy transmitted to the suture retainer 34from the horn 92 is converted into heat energy. When this occurs, thetemperature of the material forming the suture retainer 34 increases.The heat tends to concentrate at a boundary between the suture 32 andthe suture retainer 34. Thus, the heat tends to concentrate in the areaswhere the suture 32 engages the grooves 80 and 82 and the passage 76(FIG. 2).

As the temperature of the suture retainer 34 increases, the material ofthe suture retainer is heated into the transition temperature range andsoftens. However, the material of the suture retainer 34 does not meltand become liquid. As the material of the suture retainer 34 softens,the forces 96 and 98 (FIG. 3) applied against the suture retainer causethe material of the suture retainer to flow or ooze around and engagethe suture 32.

As the ultrasonic vibratory energy is effective to heat soften thematerial of the suture retainer 34, the grooves 80 and 82 close, thatis, collapse. As the grooves 80 and 82 close, the central passage 76also closes. As the grooves 80 and 82 and central passage 76 close, thesoftened material of the suture retainer 34 moves into engagement withthe suture (FIG. 3).

The viscous material of the suture retainer 34 engages the suture 32 andbonds to the suture without significant deformation of the suture. Thematerials of the suture 32 and suture retainer 34 should be chemicallycompatible so that a molecular bond can be established between thesuture retainer and the suture. Like materials, that is materials havingchemical properties which are the same or very similar will usually bondtogether. However, dissimilar materials may bond if their melttemperatures are reasonably close and they are of like molecularstructure. Generally speaking, amorphous polymers are readily bonded toeach other.

The suture retainer 34 is formed separately from the suture 32. As thematerial of the suture retainer 34 bonds to the suture 32, the sutureretainer 34 becomes fixedly connected to the suture.

If desired, heat may be transmitted directly to the suture retainer 34during the transmission of ultrasonic vibratory energy to the sutureretainer. The heat may be transmitted from a heating element disposed inthe anvil 90 and/or the horn 92. Alternatively, a separate member couldbe utilized to transmit heat to the suture retainer 34.

In the embodiment of the invention illustrated in FIGS. 1-3, the anvil90 and horn 92 have a configuration which corresponds to the arcuateconfiguration of the spherical outer side surface 84 (FIG. 2) of thesuture retainer 34. The anvil 90 and horn 92 are configured so as toengage the material of the suture retainer 34 and to be spaced from thesuture 32. This is to prevent excessive heating of the material of thesuture 32 by the direct application of ultrasonic vibratory energy tothe suture.

Embodiment of FIG. 4

In the embodiment of the invention illustrated in FIGS. 1-3, sections 38and 40 of the suture 32 are wrapped around portions 52 and 54 of thesuture retainer 34. In the embodiment of the invention illustrated inFIG. 4, a single section of the suture extends straight through apassage in the suture retainer. Since the embodiment of the inventionillustrated in FIG. 4 is generally similar to the embodiment of theinvention illustrated in FIGS. 1-3, similar terminology will be utilizedto designate similar components. It should be understood that one ormore of the features of any of the various embodiments of the inventiondisclosed herein may be used with the embodiment of the inventionillustrated in FIG. 4.

In the embodiment of the invention illustrated in FIG. 4, a suture 112is inserted through upper and lower (as viewed in FIG. 4) layers 114 and116 of human body tissue in a sterile operating room environment. Afirst or inner end portion 118 of the suture 112 is connected with asuture anchor 120. The suture anchor 120 could have any desiredconstruction, including the construction disclosed in U.S. Pat. Nos.5,584,862; 5,549,631; and/or 5,527,343. However, the illustratedembodiment of the suture anchor 120 is a circular disc or button havinga pair of central openings around which the end portion 118 of thesuture 112 is tied.

The suture 112 extends straight through the lower layer 116 and upperlayer 114 of body tissue. The two layers of body tissue are disposed inlinear apposition with each other and are compressed between the sutureanchor 120 and a suture retainer 124. The upper and lower layers 114 and116 of body tissue are compressed by force applied against the bodytissue by the suture retainer 124 and suture anchor 120. By having thelayers 114 and 116 of body tissue approximated with each other and bypressing the layers of tissue together, healing of the tissue ispromoted.

Although the layers 114 and 116 are layers of soft body tissue, thesuture 112, suture anchor 120, and suture retainer 124 could be usedwith hard body tissue in the manner disclosed in U.S. Pat. No.5,921,986. Alternatively, the suture 112, suture anchor 120, and sutureretainer 124 could be used to connect soft body tissue with hard bodytissue.

The suture retainer 124 has a spherical configuration and is formedseparately from the suture 112. A cylindrical passage 126 extendsaxially through the suture retainer 124. Although the suture 112 extendsstraight through the passage 126 in the suture retainer 124, bendsand/or loops could be formed in the suture 112 around the sutureretainer 124.

The suture retainer 124 is formed of one piece of spherical polymericmaterial having a relatively low coefficient of friction. The sutureretainer 124 may be formed of many different materials. However, it isbelieved that it may be preferred to form the suture retainer 124 of abiodegradable polymer such as polycaperlactone or polyhydroxyalkanoate.It is contemplated that other biodegradable or bioerodible polymerscould be utilized if desired. It is believed that it may be preferred toform the suture retainer 124 of an amorphous thermoplastic material.

The suture 112 may be a monofilament or may be formed of a plurality ofinterconnected filaments. The suture 112 may be biodegradable ornon-biodegradable. It is believed that it will be preferred to form thesuture 112 of the same material as the suture retainer 124. However, thesuture 112 could be formed of a material which is different than thematerial of the suture retainer. The suture 112 may be formed of anamorphous thermoplastic having chemical properties which are the same orsimilar to the chemical properties of the suture retainer 124. Forexample, both the suture retainer 124 and the suture 112 may be formedof the same biodegradable polymer, such as polycaperlactone orpolyhydroxyalkanoate.

The suture 112 is tensioned with a force which is a function of the sizeand strength of the suture. In addition, the suture retainer 124 ispressed against the upper layer 114 of body tissue with a force which isa function of the size and strength of the suture 112. Although thesuture retainer 124 is disposed in direct engagement with and is pressedagainst an outer side surface of the upper layer 114 of body tissue, aforce distribution member or button could be positioned between thesuture retainer and the upper layer 114 of body tissue.

The suture 112 is tensioned by a force application assembly 130 which isconnected with a second our outer end portion 132 of the suture 112. Theforce application assembly 130 includes a transducer or load cell 134which provides an output signal indicative of a force, indicatedschematically at 136 in FIG. 4, which is applied to the second or outerend portion 132 of the suture 112. The force 136 has a magnitude whichis a function of the size and strength of the suture 112 and thecharacteristics of the body tissue with which the suture is associated,that is, the upper layer 114 and lower layer 116 of body tissue.

The suture retainer 124 is pressed against the body tissue with a forcewhich is also a function of the strength and size of the suture 112. Aforce application member 140 is used to apply force against the sutureretainer 124. The force application member 140 has a cylindrical opening142 which extends through the force application member.

The suture 112 extends through the opening 142 in the force applicationmember 140. A slot may be formed in the force application member 140 toenable the suture to be moved into the opening 142. Alternatively, thesuture 112 could be inserted through the opening 142 before the endportion of the suture is connected with the force application assembly130.

Forces, indicated schematically at 146 and 148 in FIG. 4, are appliedagainst opposite end portions 150 and 152 of the force applicationmember 140 to press the suture retainer 124 against the upper layer 114of body tissue or against a force transmitting member disposed betweenthe suture retainer 124 and the upper layer 114 of body tissue. Thecombined force indicated schematically by the arrows 146 and 148 in FIG.4, is a function of the size and strength of the suture 112 and thecharacteristics of the layers 114 and 116 of body tissue. It iscontemplated that the combined forces 146 and 148 may be equal to theforce 136. Alternatively, the summation of the forces 146 and 148 couldexceed the force 136 or be less than the force 136.

The suture retainer 124 slides downward (as viewed in FIG. 4) along thesuture 112 under the influence of the force application member 140. Atthis time, the suture 112 is tensioned by the force application assembly130 so that the portion of the suture extending between the sutureanchor 120 and the force application assembly 130 is straight, asillustrated in FIG. 4. However, at this time, the force which is appliedto the outer end portion 132 by the force transmitting assembly may besubstantially less than the force which is indicated schematically bythe arrow 136 in FIG. 4.

After the suture retainer 124 has been moved along the suture 112 to theposition illustrated in FIG. 4, the force applied against the sutureretainer by the force application member 140 is increased. At the sametime, the force applied to the outer end portion 132 of the suture 112by the force application assembly 130 is increased. The force appliedagainst the suture retainer by the force application member 140 isincreased until the force, indicated schematically by the arrows 146 and148 in FIG. 4, is equal to a predetermined force which is a function ofthe strength of the suture 112 and the characteristics of the layers 114and 116 of body tissue. At the same time, the force applied to the outerend portion 132 of the suture 112 by the force application assembly 130is increased to the force indicated schematically by the arrow 136 inFIG. 4. As was previously mentioned, the force indicated by the arrow136 is a predetermined function of the strength of the suture 112 andthe characteristics of the layers 114 and 116 of body tissue.

While the suture 112 is being pulled straight under the influence oftension in the suture due to the force 136 and while the suture retainer124 is being pressed against the upper layer 114 of body tissue oragainst a suitable force distribution member, the suture retainer 124 isheated to grip the suture 112. In accordance with one of the features ofthe invention, the suture retainer 124 is heated by the application ofultrasonic vibratory energy to the suture retainer. The ultrasonicvibratory energy is converted into heat by the molecules of the sutureretainer 124. Thus, the mechanical ultrasonic vibrations applied againstthe suture retainer 124 cause molecular vibration of the material of thesuture retainer and a heating of the suture retainer.

When a portion of the material forming the suture retainer 124 has beenheated into its transition temperature range, the application ofultrasonic vibratory energy to the suture retainer 124 is interrupted.Heating the material forming the suture retainer 124 causes the materialto lose its rigidity and soften. The material of the suture retainer 124is not melted and does not become liquid by being heated into itstransition temperature range. The softened material of the sutureretainer 124 bonds to the suture 112 without significant deformation ofthe suture.

To apply ultrasonic vibratory energy to the suture retainer 124, asupport member or anvil 160 engages one side, that is the left side asviewed in FIG. 4, of the suture retainer 124. At the same time, a hornor acoustic tool is pressed against the opposite or right side (asviewed in FIG. 4) of the suture retainer 124.

The anvil 160 and horn 162 are pressed against opposite sides of thesuture retainer 124 with predetermined forces, indicated schematicallyby arrows 164 and 166 in FIG. 4. After the suture retainer 124 has beenfirmly clamped between the anvil 160 and horn 162, the horn is vibratedwith an ultrasonic frequency, that is with a frequency which is greaterthan 20 kilohertz. It is contemplated that the horn 162 may be vibratedat a selected frequency within a range of ultrasonic frequencies whichextends between 20 kilohertz and 70 kilohertz. Although the particularultrasonic frequency with which the horn 162 is vibrated will varydepending upon the composition and construction of the suture retainer124, it is believed that it may be preferred to vibrate the horn 162with a frequency which is close to or greater than 70 kilohertz.

The mechanical vibrations applied to the suture retainer 124 by the horn162 are effective to heat a portion of the material of the sutureretainer 124 into the transition temperature range. The heat tends toconcentrate on the portion of the suture retainer 124 adjacent to thepassage 126 and the suture 112. When the material of the suture retainer124 adjacent to the suture 112 has been heated into its transitiontemperature range, the application of ultrasonic vibratory energy to thesuture retainer 124 is interrupted. The forces 164 and 166 are effectiveto close or collapse the passage 126 and to press the softened materialof the suture retainer 124 against the suture 112.

Although the application of ultrasonic vibratory energy to the sutureretainer 124 is interrupted, the anvil 160 and horn 162 continue toapply the forces 164 and 166 against the softened material of the sutureretainer. If desired, the forces 164 and 166 may be increased when theapplication of ultrasonic vibratory energy to the suture retainer 124 bythe horn 162 is interrupted. The forces 164 and 166 firmly press theheat-softened material of the suture retainer 124 into the passage 126to collapse the passage. The heat softened material of the sutureretainer 124 is plastically deformed and pressed against the suture 112by the forces 164 and 166 applied against the suture retainer by theanvil 160 and horn 162.

The forces 164 and 166 are maintained for a sufficient period of time toenable the material of the suture retainer 124 to bond to the suture 112without significant deformation of the suture. Once this bonding hasbeen achieved, application of the forces 164 and 166 is interrupted andthe anvil 160 and horn 162 are withdrawn. The force application member140 may then be disengaged from the suture retainer and the forceapplication assembly 130 disconnected from the outer end portion 132 ofthe suture 112.

When the layers 114 and 116 of body tissue are to be interconnected withthe suture 112, suture anchor 120 and suture retainer 124, the upperlayer 114 is moved into apposition with the lower layer 116 of bodytissue. The suture 112 is then connected with the suture anchor 120 andis inserted through the layers 114 and 116 of body tissue with asuitable needle. The outer end portion 132 of the suture 112 is theninserted through the passage 126.

The suture retainer 124 is then moved along the suture 112 intoengagement with the upper layer 114 of body tissue. The forceapplication member 140 is utilized to transmit the forces 146 and 148 tothe suture retainer 124 to press the suture retainer against the upperlayer 114 of body tissue. This results in the two layers 114 and 116 ofbody tissue being pressed firmly together between the suture retainer124 and suture anchor 112. The forces 146 and 148 are transmitted to thesuture retainer 124 through the force application member 140. The suture112 is tensioned with a force 136 by the force application assembly 130.

The anvil 160 and horn 162 then compress the suture retainer 124 underthe influence of the forces 164 and 166. Ultrasonic vibratory energy istransmitted to the suture retainer. Upon heating and softening of atleast a portion of the material of the suture retainer 124, thetransmission of ultrasonic energy to the suture retainer is interruptedand a bonding of the material of the suture retainer to the suture 112occurs. After the suture retainer 124 has firmly gripped the suture 112,the application of the forces 164 and 166 is interrupted.

In the foregoing explanation of the manner in which the layers 114 and116 of body tissue are secured by the use of the suture 112, sutureanchor 120 and suture retainer 124, the suture retainer has been heatedby only the application of ultrasonic vibratory energy to the sutureretainer. However, it is contemplated that heat energy could betransmitted directly to the suture retainer along with the ultrasonicvibratory energy. If this was to be done, a heating element could beprovided in the anvil 160 and/or horn 162. If desired, a separateheating element could engage the suture retainer to transmit the heat tothe suture retainer separately from the anvil 160 and horn 162.

It is believed that it probably will be preferred to have the anvil 160and horn 162 engage the suture retainer 124 at locations spaced from thesuture 112 to prevent excessive heating of the material of the suture.If desired, protective collars could be provided around the suture 112at opposite ends of the passage 126.

Embodiment of FIG. 5

In the embodiment of the invention illustrated in FIG. 4, a singlesection of the suture 112 extends through a single passage 126 in thesuture retainer 124. In addition, in the embodiment of the inventionillustrated in FIG. 4, ultrasonic vibratory energy is applied to thesuture retainer 124 by the horn 162 which also applies a compressiveforce 166 against the suture retainer. In the embodiment of theinvention illustrated in FIG. 5, a plurality of sections of the sutureextend through a plurality of passages in the suture retainer. Inaddition, ultrasonic vibratory energy is applied to the suture retainerby a member which is separate from the members which apply force againstopposite sides of the suture retainer. Since the suture retainer of theembodiments of the invention illustrated in FIGS. 1-4 are similar to theembodiment of the suture retainer illustrated in FIG. 5, similarterminology will be utilized to designate similar components. It shouldbe understood that one or more of the features of any of the embodimentsof the invention disclosed herein may be used with the embodiment of theinvention illustrated in FIG. 5.

A tissue securing system 174 is used in a sterile, operating roomenvironment and includes a suture 176 and a suture retainer 178. Thesuture 176 has left and right sections 182 and 184 which extend intohuman body tissue 186. The body tissue 186 may include a plurality oflayers which are approximated in linear apposition with each other inthe manner previously described in conjunction with the embodiment ofthe invention illustrated in FIG. 1.

Although the suture 176 has been illustrated in FIG. 5 in associationwith soft body tissue 186, it is contemplated that the suture 176 couldbe associated with hard or hard and soft body tissue. In the embodimentof the invention illustrated in FIG. 5, the suture sections 182 and 184are interconnected by a connector section which engages the body tissuein the manner illustrated schematically in FIG. 1. However, it shouldalso be understood that the suture 176 could be associated with a sutureanchor, similar to the suture anchor 120 of FIG. 4, if desired. Ratherthan being disposed in engagement with an outer side surface of a layerof body tissue, the suture anchor could be embedded in the body tissue.

The suture retainer 178 has a spherical configuration and is formedseparately from the suture 176. A pair of parallel passages 190 and 192extend through the suture retainer 178 at locations offset to oppositesides of a central or polar axis of the suture retainer. A forcetransmitting member 194 is provided between the suture retainer 178 andthe body tissue 186.

The sections 182 and 184 of the suture 176 press against opposite sidesof the force transmitting member 194. If desired, the force transmittingmember 194 could be provided with grooves or passages to receive thesections 182 and 184 of the suture 176. The force transmitting member194 could be integrally formed as one piece with the suture retainer178. Both the force transmitting member 194 and suture retainer 178 areformed separately from the suture 176.

In accordance with a feature of this embodiment of the invention,ultrasonic vibratory energy is applied to the suture retainer 178 by ahorn or acoustic tool 200. The horn 200 extends into a cylindricalpassage 202 formed in the suture retainer 178. The passage 202 extendsparallel to and is disposed midway between the passages 190 and 192which receive the sections 182 and 184 of the suture 176.

In the embodiment of the invention illustrated in FIG. 5, the horn 200has a generally cylindrical configuration which corresponds to thecylindrical configuration of the passage 202. However, the horn 200 andpassage 202 could have different configurations if desired. For example,the horn 200 and passage 202 could have frustroconical configurations.

A pair of force application members or anvils 206 and 208 are pressedagainst opposite sides of the suture retainer 178 with predeterminedforces, indicated schematically by arrows 210 and 212 in FIG. 5. Theanvils 206 and 208 have arcuate configurations which correspond to thearcuate configuration of the suture retainer 178. Of course, the anvils206 and 208 could have a different configuration if desired.

When the tissue securing system 174 is to be utilized to secure the bodytissue 186, the suture 176 is positioned relative to the body tissue inthe manner illustrated schematically in FIG. 1. However, if desired, aseparate anchor, similar to the anchor 120 of FIG. 4, could be connectedwith an end portion of each of the sections 182 and 184 of the suture176. If this was done, the sections 182 and 184 of the suture 176 couldbe separate from each other and interconnected by the body tissue 176and suture retainer 178. Thus, two separate segments of suture, that isthe sections 182 and 184, would be interconnected by a single sutureretainer.

After the suture 176 has been positioned relative to the body tissue,the upper (as viewed in FIG. 5) end portions of the sections 182 and 184of the suture 176 are inserted through the passages 190 and 192. Theforce distribution member 194 is positioned between the suture retainer178 and the body tissue 176. The sections 182 and 184 of the suture arethen tensioned with a predetermined force. The suture retainer 178 ismoved along the sections 182 and 184 of the suture 176 into engagementwith the force distribution member 194.

When the suture retainer 178 has been moved along the sections 182 and184 of the suture 176 into engagement with the force distribution member194, a predetermined force is applied against suture retainer 178, inthe manner similar to that indicated schematically in FIG. 4, to pressthe force transmitting member 194 against the body tissue 186 with apredetermined force. At the same time, the sections 182 and 184 of thesuture 176 are tensioned with a predetermined force. If the sections 182and 184 are formed by a single piece of suture 176, in the mannerillustrated schematically in FIG. 1, a connector section of the sutureis pulled against the body tissue to compress the body tissue betweenthe suture retainer 178 and the connector section of the suture.Alternatively, if separate suture anchors are connected with thesections 182 and 184 of the suture 176, the two spaced apart sutureanchors are pulled against the body tissue to compress the body tissue186 between the suture anchors and the suture retainer 178.

While the suture 176 is being tensioned with a predetermined force andwhile the suture retainer 178 is being pressed against the forcedistribution member 194 with a predetermined force, the suture retainer178 is deformed to grip the sections 182 and 184 of the suture 176. Thisdeformation of the suture retainer 178 results in a firm gripping of thesections 182 and 184 of the suture 176 to maintain a desired tensionforce in the suture and to maintain a desired compression force againstthe body tissue 186.

To deform the suture retainer 178 to grip the suture 176, the anvils 206and 208 are pressed against opposite sides of the suture retainer with apredetermined force, as indicated schematically by the arrows 210 and210 in FIG. 5. The horn 200 is then vibrated with an ultrasonicfrequency to transmit ultrasonic vibratory energy to the suture retainer178. It is contemplated that the horn 200 may be vibrated at a frequencyof between 20 and 70 kilohertz. It is believed that it may be preferredto vibrate the horn 200 at a frequency which is close to or greater than70 kilohertz.

Vibration of the horn 200 at ultrasonic frequencies transmits mechanicalvibrational energy form the horn 200 to the suture retainer 178. Thisultrasonic vibrational energy is converted into heat energy and resultsin a heating of the suture retainer 178. The heat in the suture retainertends to be concentrated in the material of the suture retainer atlocations adjacent to the passages 190 and 192. When the material of thesuture retainer 178 adjacent to the passages 190 and 192 has been heatedinto a transition temperature range for the material, the material ofthe suture retainer becomes soft and relatively pliable. However, thematerial of the suture retainer 178 does not melt and become liquid. Thetransmission of ultrasonic vibratory energy from the horn 200 to thesuture retainer 178 is then interrupted.

The anvils 206 and 208 continue to be pressed against the sutureretainer 178 with the forces indicated schematically by the arrows 210and 212 in FIG. 5. If desired, the force applied against the sutureretainer 178 may be increased upon interruption of the transmission ofultrasonic vibratory energy to the suture retainer. The force 210 and212 applied by the anvils 206 and 208 against the suture retainer 178 iseffective to plastically deform the heat softened material of the sutureretainer. The force applied by the anvils 206 and 208 collapses thepassages 190 and 192 and presses the softened material of the sutureretainer 178 against the sections 182 and 184 of the suture 176.

The suture retainer 178 and suture 176 may be formed of many differentmaterials. However, it is believed that it will be preferred to form thesuture retainer 178 and the suture 176 of a biodegradable polymer. Thebiodegradable polymer may advantageously be an amorphous thermoplastic.Bonding of the material of the suture retainer 178 with the material ofthe suture 176 is promoted by forming the suture retainer and suture ofthe same material. However, the suture retainer 178 and suture 176 couldbe formed of different materials having similar chemical properties andwhich are compatible with each other.

In the embodiment of the invention illustrated in FIG. 5, the materialof the suture retainer 178 is heated by the application of ultrasonicvibratory energy to the suture retainer by the horn 200. However, it iscontemplated that heat energy could be directly transmitted to thesuture retainer 178 during the transmission of ultrasonic vibratoryenergy to the suture retainer if desired. To effect the transmission ofheat energy to the suture retainer 178, heating elements could beprovided in the anvils 206 and 208.

Embodiment of FIG. 6

In the embodiment of the invention illustrated in FIGS. 1-5, the sutureretainer has a generally spherical configuration and is formed as onepiece. In the embodiment of the invention illustrated in FIG. 6, thesuture retainer is formed as two pieces. Since the suture retainer ofFIG. 6 is similar to the suture retainers of FIGS. 1-5, similarterminology will be utilized to identify similar components. It shouldbe understood that one or more features of other embodiments of theinvention disclosed herein could be used with the embodiment of theinvention illustrated in FIG. 6.

A tissue securing system 218 (FIG. 6) is used in a sterile, operatingroom environment and includes a suture retainer 220 and suture 228. Thesuture retainer 220 includes two sections, that is, a left (as viewed inFIG. 6) section 222 and a right section 224. The left and right sections222 and 224 of the suture retainer 220 are formed separately from eachother. However, it is contemplated that the two sections 222 and 224could be interconnected by a flexible connector section. The flexibleconnector section may be formed as one piece with the left section 222and the right section 224 of the suture retainer 220.

A suture 228 includes sections 230 and 232 which are formed separatelyfrom the sections 222 and 224 of the suture retainer 220. The suture 228is positioned relative to human body tissue 234 with the sections 230and 232 extending away from an outer side surface 236 of the bodytissue. The suture 228 may be connected with the body tissue 234 in thesame manner as illustrated schematically in FIG. 1 if desired.

Although the suture 228 has been illustrated schematically in FIG. 6 inassociation with soft body tissue 234, it is contemplated that thesuture could be associated with hard body tissue or with both hard andsoft body tissue. It is also contemplated that the suture 228 couldextend through a suture anchor which is disposed in engagement with asurface of the body tissue or embedded in the body tissue.

The left section 222 of the suture retainer 220 has a generallyrectangular configuration. The left section 222 of the suture retainer220 includes a pair of parallel grooves 240 and 242. The grooves 240 and242 extend inward, that is, toward the left as viewed in FIG. 6, from aflat major side surface 244 of the left section 222 of the sutureretainer 220. The grooves 240 and 242 are each formed as a portion of acylinder.

Each of the grooves 240 and 242 has an extent which is slightly lessthan one-half of the circumferential extent of a cylinder. The radius ofthe grooves 240 and 242 is the same as the radius of the suture sections230 and 232. Since the grooves 240 and 242 have side surfaces which areformed as a portion of a cylinder and have an extent which is slightlyless than one-half of the diameter of the cylinder, less than half ofeach of the suture sections 230 and 232 is disposed in a groove 240 and242.

The right section 224 of the suture retainer 222 has a configurationwhich is the same as the configuration of the left section 222. Thus,the right section 224 of the suture retainer 220 includes a pair ofgroves 248 and 250. The grooves 248 and 250 extend inward, that istoward the right, as viewed in FIG. 6, from a flat major side surface252 of the right section 224 of the suture retainer 220.

The grooves 248 and 250 are each formed as a portion of a cylinder.However, the grooves 248 and 250 have an extent which is slightly lessthan one-half the circumferential extent of the cylinder. The grooves248 and 250 have a radius which is the same as the radius of the suturesections 230 and 232.

In one specific embodiment of the invention, the identical left andright sections 222 and 224 had a rectangular configuration. The majorside surfaces 244 and 252 had a length, as measured transversely to thegrooves 240, 242, 248 and 250, of approximately 0.236 inches. The majorside surfaces 244 and 252 had a width, as measured parallel to thegroves 240, 242, 248 and 250, of approximately 0.119 inches. The leftand right sections 222 and 224 had a thickness, as measuredperpendicular to the major side surfaces 244 and 252, of approximately0.055 inches. The grooves 240, 242, 248, and 250 had a radius ofapproximately 0.046 inches. The depths of the grooves 240, 242, 248 and250 was approximately 0.005 inches less than the radius of the groovesor about 0.041 inches.

It should be understood that the foregoing dimensions for one specificpreferred embodiment of the suture retainer 222 have been set forthherein for purposes of clarity of description. It is contemplated thatthe sections 222 and 224 of the suture retainer 220 will be constructedwith dimensions which are substantially different from the specificdimensions which have been set forth herein.

The two sections 222 and 224 of the suture retainer 220 may be formed ofmany different materials. However, it is believed that it will bepreferred to form the sections 222 and 224 of the suture retainer 220 ofa biodegradable polymer. The two sections 222 and 224 of the sutureretainer 220 may be formed of an amorphous thermoplastic material. Thesuture 228 and the suture retainer 220 may be formed of any of thematerials previously mentioned herein or other materials. The suture 228and the suture retainer 220 may be formed from the same material or fromdifferent materials having the same or similar chemical properties whichare compatible with each other.

When the suture 228 and suture retainer 220 are to be used to secure thehuman body tissue 234, the suture 228 is positioned relative to the bodytissue. The suture 228 may be positioned relative to the body tissue inthe manner illustrated schematically in FIG. 1. Alternatively, thesuture 228 may be connected with one or more suture anchors. Apredetermined tension force is then applied to the sections 230 and 232of the suture.

The two sections 222 and 224 of the suture retainer 220 are positionedin engagement with the sections 230 and 232 of the suture 228. Thesuture retainer 220 is pressed against the body tissue 234 with apredetermined force. This results in the body tissue being pressedbetween the suture retainer 220 and the portion of the suture connectedwith the body tissue 234. A force distribution member could be providedbetween the suture retainer 220 and body tissue 234 if desired.

The left section 222 of the suture retainer 220 is positioned inabutting engagement with the sections 230 and 232 of the suture 228 andwith the body tissue 234 in the manner illustrated schematically in FIG.6. The right section 224 of the suture retainer 220 is moved intoengagement with the sections 230 and 232 of the suture 228 and is alsopressed against the body tissue 234. At this time, the major sidesurface 252 on the right section 224 of the suture retainer 220 isspaced from and extends parallel to the major side surface 244 on theright section 222 of the suture retainer 220. The two sections 222 and224 of the suture retainer 220 are spaced apart by a distance which is afunction of the extent by which the diameters of the suture sections 230and 232 exceed the combined depth of the grooves 240 and 248 and thecombined depth of the grooves 242 and 250 in the sections 222 and 224 ofthe suture retainer 220.

In the specific example for which dimensions have been set forth herein,the major side surface 244 of the left section 222 of the sutureretainer 220 is spaced 0.010 inches from the major side surface 252 ofthe right section 224 of the suture retainer 220. It should beunderstood that a different spacing could be provided between the majorside surfaces 244 and 252 of the suture sections 222 and 224 when thegrooves 240 and 242 in the suture section 222 are in engagement with thesuture sections 230 and 232 and the grooves 248 and 250 in the rightsuture section 224 are in engagement with the suture sections 230 and232.

In order to bond the sections 222 and 224 of the suture retainer 220 toeach other and to the sections 230 and 232 of the suture 228, ultrasonicvibratory energy is transmitted to the suture retainer 220. At thistime, the suture retainer 228 is pressed against the body tissue 234with a predetermined force and the sections 230 and 232 of the suture228 are tensioned with a predetermined force.

To effect the transmission of ultrasonic vibratory energy to thesections 222 and 224 of the suture retainer 220, an anvil 258 is movedinto engagement with the left section 222 of the suture retainer 220. Ahorn or acoustic tool 260 is moved into engagement with the rightsection 224 of the suture retainer 220. The anvil 258 and horn 260 arepressed against the sections 222 and 224 of the suture retainer 220 witha predetermined force to firmly press the sections of the sutureretainer against the sections 230 and 232 of the suture 228.

While the anvil 258 and horn 260 are being pressed against the sutureretainer sections 222 and 224 with a predetermined force, ultrasonicvibrations are transmitted from the horn 260 to the suture retainer 220.The ultrasonic vibrations transmitted from the horn 260 to the sutureretainer 220 have a frequency in excess of 20 kilohertz. The ultrasonicvibrations transmitted to suture retainer 220 by the horn 260 may have afrequency of between 20 kilohertz and 70 kilohertz. It is believed thatit may be preferred to transmit ultrasonic vibrations having a frequencyclose to or greater than 70 kilohertz to the suture retainer 220 fromthe horn 260.

The ultrasonic vibrations transmitted to the suture retainer 220 createfrictional heat and cause portions of the material of the sutureretainer 220 to be heated into the transition temperature range for thematerial. As the material of the suture retainer 220 is heated into itstransition temperature range, the material loses some of its rigidityand softens. The material of the suture retainer 220 does not melt andbecome liquid. The heat in the suture retainer 220 will tend to beconcentrated adjacent to the grooves 240, 242, 248 and 250 and adjacentto the major side surfaces 244 and 252.

As the material of the suture retainer 220 is heated and softened by theultrasonic vibratory energy, the sections 222 and 224 of the sutureretainer 220 are pressed together by force applied against the sectionsof the suture retainer by the anvil 258 and horn 260. As this occurs,the material of the sections 222 and 224 of the suture retainer 220 isplastically deformed and pressed against the sections 230 and 232 of thesuture 228 at the grooves 240, 242, 248 and 250 in the suture retainer.At the same time, at least portions of the major side surfaces 248 and252 on the sections 222 and 224 of the suture retainer 220 will moveinto engagement with each other.

When this has occurred, the transmission of ultrasonic energy to thesuture retainer 228 is interrupted. However, the force applied againstthe sections 222 and 224 is maintained. It is believed that it may bedesired to increase the force applied against the sections 222 and 224of the suture retainer 220 by the anvil 258 and horn 260 as theapplication of ultrasonic vibratory energy to the suture retainer 220 isinterrupted.

While the clamping force applied by the anvil 258 and horn 260 ismaintained, the left and right sections 222 and 224 of the sutureretainer 220 bond to each other. In addition, the left and rightsections 222 and 224 of the suture retainer 220 bond to the sections 230and 232 of the suture 228. This results in the suture 228 being firmlygripped by the sections of the suture retainer 220. The sections 222 and224 of the suture retainer 220 bond to the suture 228 withoutsignificant deformation of the suture.

The left and right sections 222 and 224 of the suture retainer 220 bondto each other at a joint formed between the surfaces 244 and 252 of thesections of the suture retainer. This results in a bonding of thesections 222 and 224 of the suture retainer 220 at locations offset toboth sides of the suture 228 and at locations offset to both sides ofthe suture 230. The material of the sections 222 and 224 of the sutureretainer 220 defining the grooves 240, 242, 248 and 250 bond to theouter side surfaces of the sections 230 and 232 of the suture 228.

Although it is preferred to heat the sections 222 and 224 of the sutureretainer 220 with ultrasonic vibratory energy in the manner previouslyexplained, it is contemplated that heat energy could be directlytransmitted to the suture retainer if desired during the transmission ofultrasonic vibratory energy to the suture retainer. The heat energycould be transmitted to the suture retainer 220 from heating coils inthe anvil 258 and/or horn 260. If desired, a separate heat applicationmember could be provided.

The sections 222 and 224 of the suture retainer 220 prevent directengagement of the anvil 258 and horn 260 with the suture 228. Thisprevents excessive heating of the suture 228.

Embodiment of FIGS. 7 and 8

In the embodiment of the invention illustrated in FIG. 6, the sutureretainer 220 is formed in two sections 222 and 224. In the embodiment ofthe invention illustrated in FIGS. 7 and 8, the suture retainer isformed as one piece having passages for receiving the sections of thesuture. Since the embodiment of the invention illustrated in FIGS. 7 and8 is generally similar to the embodiment of the invention illustrated inFIGS. 1-6, similar terminology will be utilized to identify similarcomponents. It should be understood that one or more of the features ofthe other embodiments of the invention illustrated herein could beutilized in association with the embodiment of the invention illustratedin FIGS. 7 and 8.

A tissue securing system 268 is used in a sterile, operating roomenvironment and includes a suture retainer 270 and a suture 280. Thesuture retainer 270 is integrally formed as one piece and has acylindrical configuration. A pair of cylindrical passages 272 and 274(FIG. 7) extend diametrically through the suture retainer 270. Ofcourse, the suture retainer 270 and passages 272 and 274 could have adifferent configuration if desired. For example, the suture retainer 270could have an oval or a polygonal configuration.

Left and right sections 276 and 278 of a suture 280 extend through thepassages 272 and 274. The suture sections 276 and 278 are connected withlayers of human body tissue (not shown) in the same manner as has beenillustrated schematically in FIG. 1. However, the suture sections 276and 278 could be connected with a suture anchor embedded in the bodytissue. Alternatively, each of the sections 276 and 278 of the suture280 could be connected with a separate suture anchor, in much the samemanner as in which the one section of the suture 112 of FIG. 4 isconnected with the suture anchor 120.

It is contemplated that the suture retainer 270 and suture 280 could beused in association with hard body tissue, soft body tissue, or hard andsoft body tissue. The suture retainer 270 and suture 280 may be usedwith body tissue in any one of the ways previously described herein. Ofcourse, the suture retainer and suture may be used with body tissue inother known ways if desired.

The suture retainer 270 may be formed of many different materials.However, It is believed that it will be preferred to form the sutureretainer 270 of a biodegradable polymer. It is believed that it may bepreferred to form both the suture retainer 270 and the suture 280 of thesame amorphous thermoplastic material. However, if desired, the suture280 and suture retainer 270 could be formed of different materials whichhave the same or similar chemical properties and are compatible witheach other. The suture 280 and/or the suture retainer 270 may be formedof either biodegradable or non-biodegradable materials.

In one specific embodiment of the invention, the cylindrical sutureretainer 270 had a diameter of 0.119 inches. This particular sutureretainer 270 had an axial extent of 0.236 inches. The passages 272 and274 each had a diameter of 0.046 inches. If desired, the passages 272and 274 could be formed with an oval configuration with parallel flatsurfaces having a length of 0.030 inches extending between semicircularopposite end portions of the ovals.

It should be understood that the foregoing specific dimensions forembodiments of the suture retainer 270 have been set forth herein forpurposes of clarity of description. It is contemplated that the sutureretainer 270 can and will be formed with dimensions which are differentthan these specific dimensions. It is also contemplated that the sutureretainer 270 will be constructed with a configuration which is differentthan the specific configuration illustrated herein. For example, thesuture retainer 270 could have a prismatic configuration with thepassages 272 and 274 extending between one corner portion and a sidesurface of the prism.

The suture 280 is positioned relative to body tissue in much the samemanner as illustrated in FIG. 1. The sections 276 and 278 of the suture280 are then inserted through the passages 272 and 274 (FIG. 7). Whilethe suture 280 is tensioned, the suture retainer 270 is moved along thesuture toward the body tissue. A predetermined force is transmitted fromthe suture retainer 270 to the body tissue while the sections 276 and278 of the suture 280 are tensioned with a predetermined force in themanner previously described in conjunction with the embodiment of theinvention illustrated in FIG. 4.

While the body tissue is compressed between the suture 280 and thesuture retainer 270, ultrasonic vibratory energy is transmitted to thesuture retainer 270. To transmit ultrasonic vibratory energy to thesuture retainer 270, an anvil 286 (FIG. 8) and a horn or acoustic tool288 are pressed against opposite sides of the suture retainer 270 with apredetermined force. The suture 280 is tensioned and the suture retainer270 is pressed against body tissue with predetermined forces while theanvil 286 and horn 288 are pressed against the suture retainer.

The horn 288 is then vibrated at an ultrasonic frequency, that is, at afrequency greater than 20 kilohertz. The horn 280 may be vibrated at afrequency of between 20 and 70 kilohertz. It is believed that it may bepreferred to vibrate the horn 288 at a frequency close to or greaterthan 70 kilohertz. As this occurs, vibratory mechanical energy atultrasonic frequencies is transmitted from the horn 288 to the sutureretainer 270.

The ultrasonic vibratory energy transmitted from the horn 288 to thesuture retainer 270 is effective to heat the suture retainer. The heattends to be concentrated in the portion of the suture retainer 270adjacent to the sections 276 and 278 of the suture 280.

When the portion of the suture retainer 270 adjacent to the sections 276and 278 of the suture 280 have been heated to a temperature in thetransition temperature range for the material of the suture retainer270, the application of ultrasonic vibratory energy to the sutureretainer 270 by the horn 288 is interrupted. When material of the sutureretainer 270 is heated into the transition temperature range, thematerial of the suture retainer becomes soft and pliable. Although thematerial of the suture retainer 270 does not melt and become liquid, thematerial of the suture retainer 270 is softened and loses its rigiditywhen it is heated into the transition temperature range.

The force applied against the suture retainer 270 is then maintained orincreased. The force applied against the suture retainer 270 by theanvil 286 and horn 288 is effective to plastically deform the materialof the suture retainer. As the heat softened material of the sutureretainer 270 is plastically deformed by the anvil 286 and horn 288, thematerial of the suture retainer is firmly pressed against the sections276 and 278 of the suture 280.

As the heated and softened material of the suture retainer 270 cools,the material of the suture retainer bonds to the suture 280. Thisresults in the suture retainer 270 securely gripping the sections 276and 278 of the suture 280. The suture 280 is not significantly deformedas the suture retainer 270 is heated and bonded to the suture.Therefore, the strength of the suture 280 is not significantly reduced.

In the foregoing description, the suture retainer 270 was heated by theapplication of ultrasonic vibratory energy to the suture retainer. It iscontemplated that heat energy could be transmitted to the sutureretainer 270 along with the ultrasonic vibratory energy. This could beaccomplished in many different ways. For example, a heating elementcould be provided in the anvil 286 and/or horn 288. Alternatively, aseparate heating element could be moved into contact with the sutureretainer 270.

Embodiment of FIG. 9

In the embodiment of the invention illustrated in FIGS. 7 and 8, thesuture 280 extends through passages 272 and 274 formed in the sutureretainer 270. In the embodiment of the invention illustrated in FIG. 9,the suture is wrapped around a section of the suture retainer and isengaged by other sections of the suture retainer. Since the sutureretainer of the embodiments of the invention illustrated in FIGS. 1-8 issimilar to the suture retainer of the embodiment of the inventionillustrated in FIG. 9, similar terminology will be utilized to identifysimilar components. It should be understood that one or more features ofother embodiments of the invention disclosed herein may be used with theembodiment of the invention illustrated in FIG. 9.

A tissue securing system 291 is used in a sterile, operating roomenvironment and includes a suture retainer 292 and a suture 302. Thesuture retainer 292 includes a cylindrical central section 294 which isdisposed between left and right side sections 296 and 298. The centralsection 294 is formed separately from the side sections 296 and 298. Theside sections 296 and 298 are formed separately from each other.However, the side sections 296 and 298 could be interconnected ifdesired. For example, the side sections 296 and 298 could be integrallyformed as one piece with a flexible connector section which extendsbetween the side sections. Alternatively, the central section 294 andside sections 296 and 298 could be formed as one piece.

A suture 302 is wrapped around the central section 294. The suture 302is received in a groove 304 in the central section 294. The groove 304has a circular configuration and has a central axis which is coincidentwith a central axis of the cylindrical central section 294.

The groove 304 has an extent which is greater than 360° and extendscompletely around the central section 294 of the suture retainer 292.The groove 304 is formed as a portion of a helix. Opposite end portionsof the groove 304 are disposed in an overlapping relationship on thecentral portion 294 of the suture retainer 292. The suture 302 isdisposed in the groove 304 throughout the extent of its engagement withthe central section 294.

Although the groove 304 has been shown as having somewhat more than asingle turn in FIG. 8, the groove could have a plurality of turns aroundthe central section 294 of the suture retainer 292 if desired. If thiswas done, the suture 302 would be wrapped a plurality of times aroundthe central section 294. Thus, rather than having a single wrap of thesuture 302 around the central section 294 of the suture retainer 292 inthe manner illustrated in FIG. 9, the suture 302 could be wrapped aplurality of times around the central section of the suture retainer294.

The suture 302 and suture retainer 292 may be formed of the samematerial or different materials. Similarly, the central section 294 andside sections 296 and 298 may be formed of the same material ordifferent materials. It is believed that it may be preferred to form thesuture 302 and the suture retainer 294 from biodegradable materials.However, the suture 302 and/or the suture retainer 292 could be formedof materials which are not biodegradable. It may also be preferred toform the suture retainer 292 and suture 302 of an amorphous polymericmaterial. The suture retainer 292 and suture 302 may be formed of any ofthe materials previously mentioned herein or other materials.

When the suture retainer 292 is to be utilized to secure human bodytissue, the suture 302 is positioned relative to the body tissue in themanner illustrated in FIG. 4. Of course, the suture 302 could bepositioned relative to body tissue in a different manner if desired. Thesuture 302 and suture retainer 292 may be used with hard, soft, or hardand soft body tissue.

The suture 302 is wrapped around the central section 294 of the sutureretainer, in the manner illustrated schematically in FIG. 9. Once thesuture 302 has been wrapped around the central section 294 of the sutureretainer 292, the central section of the suture retainer is moved alongthe suture 302 toward the body tissue.

As the central section 294 of the suture retainer 292 moves toward thebody tissue, a wrap or turn of the suture 302 around the central sectionof the suture retainer moves along the suture toward the body tissue.The central section 294 of the suture retainer 292 may be moved along astraight path toward the body tissue without rotating while tension ismaintained in the suture 302 and the suture slides along the groove 304in the central section of the suture retainer. Alternatively, thecentral section 294 of the suture retainer could be rolled along thesuture 302 toward the body tissue.

The central section 294 of the suture retainer 292 is moved along thesuture 302 until the central section of the suture retainer engages thebody tissue in the manner illustrated in FIG. 4 or engages a forcedistribution member in the manner illustrated in FIG. 5. A predeterminedtension force is then applied to the suture 302 and the central section294 of the suture retainer is urged toward the body tissue with apredetermined force. The body tissue engaged by the suture 302 iscompressed between the central section 294 of the suture retainer 292and a suture anchor, similar to the suture anchor 120 of FIG. 4.

While the suture 302 is tensioned with a predetermined force and apredetermined force is transmitted from the central section 294 of thesuture retainer 292 to the body tissue, the side sections 296 and 298are aligned with the central section 294 of the suture retainer. Theside sections 296 and 298 have concave surfaces 310 and 312 which arepressed against the turn in the suture 302 which extends around thecentral portion 294 of the suture retainer 292. The surfaces 310 and 312have an arc of curvature which is the same as the arc of curvature of agenerally cylindrical outer side surface 314 on the side sections 296and 298. However, since the suture 302 projects out of the groove 304,the side surfaces 310 and 312 on the side sections 296 and 298 areslightly spaced from the side surface 314 on the central section 294 ofthe suture retainer 292.

In accordance with a feature of the present invention, ultrasonicvibratory energy is applied to the suture retainer 292. To apply theultrasonic vibratory energy to the suture retainer 292, a support memberor anvil 320 is pressed against the side section 296 of the sutureretainer 292. A horn or acoustic tool 322 is pressed against the sidesection 298 of the suture retainer 292. The anvil 320 and horn 322 arepressed against the opposite side sections 296 and 298 of the sutureretainer 292 with a predetermined force.

While the suture retainer 292 is clamped between the anvil 320 and horn322, mechanical vibrations at an ultrasonic frequency are transmittedfrom the horn 322 to the suture retainer 292. The ultrasonic vibratoryenergy is transmitted from the horn 322 to the suture retainer 292 atfrequency above 20 kilohertz. The horn 322 may transmit the ultrasonicvibratory energy to the suture retainer 292 at a frequency between 20kilohertz and 70 kilohertz. It is contemplated that it may be desired tohave the ultrasonic vibratory energy transmitted to the suture retainerat a frequency close to or greater than 70 kilohertz. However, it shouldbe understood that the ultrasonic vibratory energy could be transmittedto the suture retainer 292 at any desired frequency above the frequencynormally detected by the human ear, that is above approximately 20kilohertz.

The ultrasonic vibratory energy transmitted to the suture retainer 292is converted into heat. The heat tends to concentrate at the jointsbetween the side sections 296 and 298 and central section 294 of thesuture retainer 292. This results in the material forming the sidesections 296 and 298 and the central section 294 of the suture retainer292 being heated into the transition temperature range of the materialforming the suture retainer. The application of the ultrasonic vibratoryenergy to the suture retainer 292 by the horn 322 is then interrupted.

As the material of the suture retainer 292 is heated into its transitiontemperature range, the material loses its rigidity and softens. Theanvil 320 and horn 322 apply force against the suture retainer 292 toplastically deform the material of the suture retainer. The softenedside surfaces 310 and 312 on the side sections 296 and 298 are pressedagainst and are indented by the suture 302. As this occurs, the softenedside surfaces 310 and 312 of the side sections 296 and 298 move intoengagement with the softened side surface 314 on the central section 294of the suture retainer 292.

Although the application of ultrasonic vibratory energy to the sutureretainer 292 is interrupted, the anvil 320 and horn 322 continue to bepressed against the side sections 296 and 298 of the suture retainer 292with a predetermined force. If desired, the force with which the anvil320 and horn 322 are pressed against the suture retainer 292 can beincreased as the transmission of ultrasonic vibratory energy to thesuture retainer is interrupted.

As the material of the suture retainer 292 cools, the side sections 296and 298 are bonded to the central section 294 of the suture retainer292. In addition, the suture 302 is bonded to the central section 294and to the side sections 296 and 298 of the suture retainer 292.

The groove 304 in the central section 294 of the suture retainer 292 isdeep enough to prevent significant deformation and loss of strength ofthe suture 302. As the heat softened material of the side sections 296and 298 of the suture retainer is pressed against the suture 302, thematerial of the side sections is plastically deformed.

It is contemplated that bonding of the suture 302 with the centralsection 294 and side sections 296 and 298 of the suture retainer 292 maybe promoted by forming the suture and the sections of the sutureretainer of the same material. The material may be an amorphousthermoplastic which is biodegradable.

If desired, the groove 304 could be omitted from the central section 294of the suture retainer 292. Alternatively, the groove 304 could bedeepened so that the groove has a depth which is equal to or slightlygreater than the diameter of the suture 302. If desired, the groove 304could be formed with an undercut configuration so that the portion ofthe suture 302 in the groove 304 is not exposed to the side sections 296and 298 of the suture retainer 292. If this was done, the suture 302would be bonded to only the central section 294 of the suture retainer292 and would not be bonded to the side sections 296 and 298 of thesuture retainer.

If the configuration of groove 304 is changed to an undercutconfiguration, the suture 302 would be completely enclosed by thegroove. A groove having this configuration is disclosed in U.S. Pat. No.6,010,525 which has been and hereby is incorporated herein in itsentirety. If the groove 304 has such an undercut configuration, the sidesections 296 and 298 could be eliminated. The anvil 320 and horn 322would then be pressed against opposite sides of the cylindrical outerside surface 314 of the central section 294 in the same manner as isdisclosed in FIG. 8 in association with the suture retainer 270. As isdisclosed in the aforementioned U.S. Pat. No. 6,010,525, the groove andsuture could extend for a plurality of turns around the central portion294 of the suture retainer 292.

In the foregoing description, it has been assumed that only ultrasonicvibrational energy may be transmitted to the suture retainer 292 toeffect a bonding of the suture retainer and the suture 302. However,thermal energy in the form of heat could be directly applied to thesuture retainer 292 if desired. This could be accomplished in manydifferent ways. For example, a heating element could be provided in theanvil 320 and/or the horn 322.

Embodiment of FIGS. 10 and 11

In the embodiment of the invention illustrated in FIG. 9, the suture 302is wrapped around a central section 294 of the suture retainer 292. Inthe embodiment of the invention illustrated in FIGS. 10 and 11, sectionsof the suture extend through passages in a central section of the sutureretainer. Since the embodiment of the invention illustrated in FIGS. 10and 11 is generally similar to the embodiments of the inventionillustrated in FIGS. 1-9, similar terminology will be utilized toidentify similar components. It should be understood that one or more ofthe features of the other embodiments of the invention disclosed hereincould be used with the embodiment of the invention illustrated in FIGS.10 and 11 if desired.

A tissue securing system 328 is used in a sterile, operating roomenvironment and includes a suture 330 and suture retainer 340. Thesuture 330 (FIGS. 10 and 11) has a pair of sections 332 and 334 whichare connected with human body tissue. The sections 332 and 334 of thesuture 330 may connected with body tissue in the manner illustratedschematically in FIG. 1. The sections 332 and 334 of the suture 330extend through a central section 338 of the suture retainer 340 (FIG.11). In addition to the central section 338, the suture retainer 340includes a pair of side sections 342 and 344.

The central section 338 and side sections 342 and 344 all haverectangular configurations. However, the central and side sections 338,342 and 344 (FIG. 11) could have a different configuration if desired.The central section 338 is thinner (as viewed in FIG. 11) than the sidesections 342 and 344. The sections 332 and 334 of the suture 330 extendthrough cylindrical passages 348 and 350 in the central section 338.

The relatively thin central section 338 and the relatively thick sidesections 342 and 344 of the suture retainer 340 are formed of abiodegradable material. The suture 330 is also formed of a biodegradablematerial. The suture 330 and suture retainer 340 may be formed of thesame biodegradable material. It may be preferred to form the suture 330and suture retainer 340 of an amorphous polymer. If desired, the suture330 and suture retainer 340 could be formed of different materials whichare compatible and have the same or similar chemical properties. Thesuture 330 and suture retainer 340 may be formed of any of the materialspreviously mentioned herein or of other known materials.

When the suture 330 and suture retainer 340 are to be used to securehuman body tissue, the sections 332 and 334 of the suture 330 arepositioned relative to body tissue in a manner similar to that disclosedin FIG. 1. The sections 332 and 334 of the suture 330 are then insertedthrough the passages 348 and 350 in the central section 338 of thesuture retainer 340. While the suture 330 is tensioned, the centralsection 338 of the suture retainer 340 is moved along the suture towardthe body tissue.

The central section 338 of the suture retainer 340 is pressed againsteither the body tissue in the manner illustrated schematically in FIG. 4or against a force distribution member in the manner illustratedschematically in FIG. 5. While a predetermined force is transmitted fromthe central section 338 of the suture retainer 340 to the body tissueand while the sections 332 and 334 of the suture 330 are tensioned witha predetermined force, the thick side sections 342 and 344 of the sutureretainer 340 are positioned in engagement with opposite sides of thethin central section 338, in the manner illustrated in FIG. 11.

An apparatus for transmitting ultrasonic vibratory energy to the sutureretainer 340 is then moved into engagement with the side sections 342and 344 of the suture retainer. The apparatus for applying ultrasonicvibratory energy to the suture retainer 340 includes an anvil or supportportion 354 and a horn or acoustic tool 356. The anvil 354 and horn 356are pressed against opposite sides of the suture retainer with apredetermined force. While the suture retainer 340 is clamped betweenthe anvil 354 and horn 356, ultrasonic vibratory energy is transmittedfrom the horn 356 to the suture retainer 340.

The ultrasonic vibratory energy transmitted from the horn 356 to thesuture retainer 340 is effective to heat the material of the sutureretainer. The heat tends to be concentrated at the joints between thethick side sections 342 and 344 and the thin central section 338 of thesuture retainer 340. In addition, the heat tends to be concentrated atthe joint between the sections 332 and 334 of the suture and the centralsection 338 of the suture retainer. This results in a substantialportion of the material of the thin central section 338 of the sutureretainer 340 being heated into its transition temperature range.

As the material of the suture retainer 340 is heated into its transitiontemperature range, the material of the suture retainer loses itsrigidity and becomes soft. However, the material of the suture retaineris not heated enough to melt the material of the suture retainer. Sincethe central section 338 is relatively thin, the material of the centralsection becomes very pliable while the side sections 342 and 344 stillhave some rigidity.

Once a substantial portion of the material of the central section 338 ofthe suture retainer 340 has been softened by being heated into itstransition temperature range, the transmission of ultrasonic vibratoryenergy from the horn 356 to the suture retainer 340 is interrupted.However, the anvil 354 and horn 356 continue to apply force againstopposite sides of the suture retainer 340. The magnitude of the forceapplied against opposite sides of the suture retainer 340 by the anvil354 and horn 356 may be increased as the transmission of ultrasonicvibratory energy from the horn 356 to the suture retainer 340 isinterrupted. The force applied against opposite sides of the sutureretainer 340 by the anvil 354 and horn 356 is effective to plasticallydeform the heat softened material of the suture retainer 340.

As the suture retainer 340 cools, the side sections 342 and 344 of thesuture retainer are bonded to the central section 338 of the sutureretainer. In addition, the central section 338 of the suture retainer340 is bonded to the sections 332 and 334 of the suture 330. Thisresults in the suture 330 being securely gripped by the suture retainer340. However, there is no significant deformation of the suture 330 sothat the strength of the suture 330 is not significantly reduced.

In the foregoing description, the material of the central section 338 ofthe suture retainer 340 was heated by the transmission of ultrasonicvibratory energy to the suture retainer 340. However, it is contemplatedthat thermal energy could be applied to the suture retainer 340 alongwith the ultrasonic vibratory energy. This could be accomplished byproviding a heating element in the anvil 354 and/or horn 356.Alternatively, a separate member could be utilized to apply heatdirectly to the suture retainer 340.

The anvil 354 and horn 356 engage only the suture retainer 340. Theanvil 354 and horn 356 are maintained in a spaced apart relationshipwith the suture 330. This prevents excessive heating and/or deformationof the suture.

Embodiment of FIGS. 12 and 13

In the embodiment of the invention illustrated in FIGS. 10 and 11, thesections of the suture extend through passages in a central section ofthe suture retainer. In the embodiment of the invention illustrated inFIGS. 12 and 13, the sections of the suture are disposed in groovesformed in the central section of the suture retainer. Since theembodiment of the invention illustrated in FIGS. 12 and 13 is generallysimilar to the embodiments of the invention illustrated in FIGS. 1-11,similar terminology will be utilized to designate similar components. Itshould be understood that one or more of the features of otherembodiments of the invention disclosed herein could be used with theembodiment of the invention illustrated in FIGS. 12 and 13.

A tissue securing system 359 (FIGS. 12 and 13) is used in a sterile,operating room environment and includes a suture 360 and a sutureretainer 368. The suture 360 has left and right sections 362 and 364.The sections 362 and 364 of the suture 360 are connected with human bodytissue in a manner similar to the manner illustrated schematically inFIG. 1. However, the sections 362 and 364 of the suture 360 could beconnected with body tissue in a different manner if desired. Forexample, the sections 362 and 364 could be connected with a sutureanchor embedded in the body tissue. Alternatively, a separate sutureanchor could be provided for each of the sections 362 and 364 of thesuture 360.

A suture retainer 368 includes a central section 370. A pair of sidesections 372 and 374 are disposed on opposite sides of the centralsection 370. The central section 370 and side sections 374 all have agenerally rectangular configuration. However, the central section 370 isthinner than the side sections 372 and 374 (FIG. 13).

A pair of grooves 378 and 380 are provided in the central section 370.The grooves 378 and 380 have parallel longitudinal central axes. Thegrooves 378 and 380 are disposed in opposite sides of the centralsection 370 and open in opposite directions.

In addition, a groove 384 is formed in the side section 372. The groove384 extends parallel to and is aligned with the groove 380 in thecentral section 370. Similarly, a groove 386 is formed in the sidesection 374. The groove 386 extends parallel to and is aligned with thegroove 378 in the central section 370. The section 362 of the suture 360is received in the grooves 378 and 386 (FIG. 13). Similarly, the section364 of the suture 360 is received in the grooves 380 and 384.

The grooves 378 and 386 are aligned with each other and are offset toone side of the grooves 380 and 384. This results in the sections 362and 364 of the suture 360 being offset from each other (FIG. 13).However, if desired, the grooves 378 and 386 and the grooves 380 and 384could all be aligned. This would result in the sections 362 and 364 ofthe suture being aligned with each other.

The central section 370 and side sections 372 and 374 of the sutureretainer 368 are formed of a biodegradable material. The suture 360 isalso formed of a biodegradable material. The suture 360 and sutureretainer 368 may be formed of the same biodegradable material. It may bepreferred to form the suture 360 and suture retainer 368 of an amorphouspolymer. If desired, the suture 360 and suture retainer 368 could beformed of different materials which are compatible and have the same orsimilar chemical properties. It is contemplated that the suture 360 andsuture retainer 368 could be formed of any of the materials previouslymentioned herein or of other materials.

The suture 360 is positioned relative to body tissue in the same manneras is illustrated schematically in FIG. 1. While the sections 362 and364 of the suture are tensioned with a predetermined force, the centralsection 370 of the suture retainer 368 is positioned relative to thesections 362 and 364 of the suture 360. In addition, the side sections372 and 374 are positioned relative to the sections 362 and 364 of thesuture and relative to the central section 370. The central section 370and side sections 372 and 374 of the suture retainer 368 are urgedtoward the body tissue in the manner illustrated schematically in FIG.4. This results in the transmission of a predetermined force from thesuture retainer 360 to the body tissue while the sections 362 and 364 ofthe suture 360 are tensioned with a predetermined force.

In accordance with one of the features of the present invention,ultrasonic vibratory energy is then transmitted to the suture retainer368. To transmit ultrasonic vibratory energy to the suture retainer 368,an anvil or support member 390 (FIG. 13) is pressed against the sidesection 372 of the suture retainer 368. In addition, a horn or acoustictool 392 is pressed against the side section 374 of the suture retainer368. While the suture retainer 368 is clamped between the anvil 390 andhorn 392, ultrasonic vibratory energy is transmitted from the horn tothe suture retainer.

The ultrasonic vibratory energy transmitted from the horn 392 to thesuture retainer 368 may have a frequency in a range between 20 kilohertzand 70 kilohertz. It is believed that it will be preferred to transmitultrasonic vibratory energy having a frequency of approximately 70kilohertz or more from the horn 392 to the suture retainer 368.

The ultrasonic vibratory energy is effective to heat the suture retainer368. The heat is concentrated at the joints between the thin centralsection 370 and thick side sections 372 and 374 of the suture retainer368. Since the central section 370 is thinner than the side sections 372and 374, a substantial percentage of the material of the central section370 is heated into its transition temperature range while a smallerpercentage of the material of the side sections 372 and 374 is heatedinto its transition temperature range.

Heating the material of the suture retainer 368 into the transitiontemperature range is effective to cause the material of the sutureretainer to soften and lose its rigidity. Although the material of thesuture retainer 368 softens, the material does not melt and becomeliquid. The softened material of the suture retainer is pliable andplastically deforms under the influence of the clamping force applied bythe anvil 390 and horn 392.

As the material of the suture retainer 368 plastically deforms, a flatmajor side surface 396 on the central section 370 of the suture retainer368 and a flat side surface 398 on the side section 372 of the sutureretainer move into engagement. At the same time, a flat side surface 402on the central section 370 of the suture retainer 368 and a flat sidesurface 404 on the side section 374 of the suture retainer move intoengagement. As this occurs, the softened material of the central section370 of the suture retainer 368 is deformed by force applied to thecentral section through the sections 362 and 364 of the suture 360.

After material of the suture retainer 368 has been heated into itstransition temperature range, the application of ultrasonic vibratoryenergy to the suture retainer is interrupted. However, the forcepressing the anvil 390 and the horn 392 against the suture retainer ismaintained. If desired, the magnitude of the force applied against thesuture retainer 368 by the anvil 390 and horn 392 may be increasedsimultaneously with the interruption of the application of ultrasonicvibratory energy to the suture retainer.

As the material of the suture retainer 368 cools, the flat major sidesurface 396 on the central section 370 bonds to the flat major sidesurface 398 on the side section 372. In addition, the flat major sidesurface 402 on the central section 370 bonds to the flat major sidesurface 404 on the side section 374. The surfaces defining the grooves378 and 380 in the central section 370 of the suture retainer 368 bondto the sections 362 and 364 of the suture 360. The surfaces defining thegrooves 384 and 386 in the side sections 372 and 374 of the sutureretainer 368 also bond to the sections 362 and 364 of the suture 360.

In the foregoing description, the suture retainer 368 was heated by theapplication of ultrasonic vibratory energy to the suture retainer. It iscontemplated that the suture retainer 368 could also be heated by thedirect application of thermal energy to the suture retainer. If this isto be done, a heating element could be provided in the anvil 390 and/orhorn 392. If desired, a separate heating element could be moved intoengagement with the suture retainer to transmit heat to the sutureretainer.

The anvil 390 and horn 392 engage only the suture retainer 368. Theanvil 390 and horn 392 are maintained in a spaced apart relationshipwith the suture 360. This prevents excessive heating and/or deformationof the suture 360.

Embodiment of FIGS. 14 and 15

In the embodiment of the invention illustrated in FIGS. 12 and 13,straight sections 362 and 364 of the suture 360 are connected with thesuture retainer 368. In the embodiment of the invention illustrated inFIGS. 14 and 15, sections of the suture are wrapped around a portion ofthe suture retainer. Since the embodiment of the invention illustratedin FIGS. 14 and 15 is generally similar to the embodiments of theinvention illustrated in FIGS. 1-13, similar terminology will beutilized to describe similar components. It should be understood thatone or more of the features of other embodiments of the invention couldbe utilized in association with the embodiment of the inventionillustrated in FIGS. 14 and 15 if desired.

A tissue securing system 408 (FIG. 15) is used in a sterile, operatingroom environment and includes a suture 410 and a suture retainer 418.The suture 410 includes left and right sections 412 and 414. The leftand right sections 412 and 414 of the suture 410 are connected withhuman body tissue in the manner illustrated schematically in FIG. 1.Alternatively, the left and right sections 412 and 414 of the suture 410could be connected with a single suture anchor. If desired, a sutureanchor could be provided in association with each of the sections 412and 414 of the suture 410.

The suture retainer 418 (FIG. 15) includes a central section 420 and apair of side sections 422 and 424. The central section 420 and sidesections 422 and 424 of the suture retainer 418 are formed of abiodegradable material. The suture 410 is also formed of a biodegradablematerial. The suture 410 and suture retainer 418 may be formed of thesame biodegradable material. It may be preferred to form the suture 410and suture retainer 418 of an amorphous polymer. If desired, the suture410 and suture retainer 418 could be formed of different materialshaving the same or substantially similar chemical properties. The suture410 and suture retainer 418 could be formed of any of the materialspreviously mentioned herein or other materials.

When the suture retainer 418 is to be utilized to secure body tissue,the suture sections 412 and 414 are wrapped around the central section420 of the suture retainer in the manner illustrated schematically inFIG. 14. While the sections 412 and 414 of the suture 410 are tensioned,the central section 420 of the suture retainer is moved along the suture410 toward the body tissue. Of course, the turns or wraps formed aroundthe central section 420 of the suture retainer 418 are moved toward thebody tissue along with the central section.

The central section 420 of the suture retainer is moved into engagementwith the body tissue or with a force distribution member in the mannersimilar to that illustrated in either FIG. 4 or FIG. 5. While apredetermined force is transmitted from the central section 420 of thesuture retainer to the body tissue, the sections 412 and 414 of thesuture 410 are tensioned with a predetermined force. This results in thebody tissue being compressed under the influence of force beingtransmitted to the body tissue from the central section 420 of thesuture retainer 418 and from the suture 410.

While the suture is being tensioned with a predetermined force and whilethe predetermined force is being transmitted from the central section420 of the suture retainer 418, the side sections 422 and 424 are movedinto juxtaposition with the central section 420 of the suture retainer418. The side sections 422 and 424 are thicker than the central section420. Force is also transmitted from the side sections 422 and 424 to thebody tissue.

To effect the application of ultrasonic vibratory energy to the sutureretainer 418, and anvil or support portion 428 is pressed against therelatively thick side section 422 of the suture retainer 418. At thesame time, a horn or acoustic tool 430 is pressed against the relativelythick side section 424 of the suture retainer 418. This results in thesuture retainer 418 being clamped between the anvil 428 and horn 430with a predetermined force. The clamping force presses the suture 410against the relatively thin central section 420 of the suture retainer.

While maintaining the predetermined clamping force on the sutureretainer 418, ultrasonic vibratory energy is transmitted from the horn430 to the suture retainer. The ultrasonic vibratory energy istransmitted at a frequency of between 20 kilohertz and 70 kilohertz. Itis believed that it may be preferred to transmit the ultrasonicvibratory energy at a frequency close to or greater than 70 kilohertz.

The ultrasonic vibratory energy is effective to heat the suture retainer418. The heat tends to be concentrated at the joints between the thincentral section 420 and thick side sections 422 and 424 of the sutureretainer 418. Since the central section 420 of the suture retainer 418is thinner than the side sections 422 and 424 of the suture retainer, alarger percentage of the material of the central section 420 of thesuture retainer 418 is heated into its transition temperature range bythe ultrasonic vibratory energy before a corresponding percentage of theside sections 422 and 424 is heated into the transition temperaturerange.

When the material of the suture retainer 418 has been heated into itstransition temperature range, the material becomes soft and pliable. Theclamping force applied against the side sections 422 and 424 causes theturns in the sections 412 and 414 of the suture 410 to indent andplastically deform the heat softened material of the central section 420and side sections 422 and 424. As this occurs, the side sections 422 and424 move into abutting engagement with the central section 410 under theinfluence of the clamping force applied by the anvil 428 and horn 430.

Once the material of the central section 420 and side sections 422 and424 adjacent to the turns in the sections 412 and 414 of the suture 410have been heated into the transition temperature range, the applicationof ultrasonic vibratory energy to the suture retainer 418 isinterrupted. However, the clamping force applied against the sutureretainer by the anvil 428 and horn 430 is maintained constant orincreased as the application of ultrasonic vibratory energy to thesuture retainer is interrupted. As the material of the suture retainer418 cools, while the suture retainer is clamped between the anvil 428and horn 430, the side sections 422 and 424 of the suture retainer 418bond to the central section 420 of the suture retainer. In addition, theside sections 422 and 424 and the central section 420 of the sutureretainer 418 bond to the suture 410.

Embodiment of FIGS. 16 and 17

In the embodiments of the invention illustrated in FIGS. 9 through 15,the suture retainer is formed by a plurality of sections which arebonded together. In the embodiment of the invention illustrated in FIGS.16 and 17, the suture retainer is formed as one piece. Since the sutureretainer in the embodiment of FIGS. 16 and 17 is generally similar tothe suture retainers of FIGS. 1-16, similar terminology will be utilizedto identify similar components. It should be understood that one or moreof the features of any of the other embodiments of the inventiondisclosed herein could be utilized with the embodiment of the inventionillustrated in FIGS. 16 and 17.

A tissue securing system 438 is used in a sterile, operating roomenvironment and includes a suture 440 and a suture retainer 448. Thesuture 440 includes left and right sections 442 and 444. The left andright sections 442 and 444 of the suture 440 are connected with humanbody tissue in a manner similar to the manner illustrated schematicallyin FIG. 1. However, the suture 440 could be connected with body tissuein a different manner if desired. For example, the sections 442 and 444could be connected with a single suture anchor embedded in body tissue.Alternatively, a separate suture anchor could be provided for each ofthe sections 442 and 444 if desired.

A one-piece suture retainer 448 is formed separately from the suture440. The suture retainer 448 has a generally H-shaped configuration. Thesuture retainer 448 includes a rectangular base section 450 and a pairof arm sections 452 and 454. The arm sections 452 and 454 are connectedwith the base section 450 by a connector section 456. Although only theone side, which may be considered as the top side of the suture retainer448 is illustrated in FIG. 16, the suture retainer has a generallyrectangular configuration. The extent of the suture retainer 448 alongthe sections 442 and 444 of the suture 440 may be equal to the distancebetween longitudinal central axes of the sections of the suture.

The suture retainer 448 has a pair of recesses 460 and 462 in which thesections 442 and 444 of the suture 440 are received. An entrance 466 tothe recess 460 (FIG. 17) is partially blocked by a nose or detentportion 468 of the arm section 452. When the suture section 442 is to bemoved into the recess 460, the cylindrical outer side surface of thesuture section 442 is pressed against a cam surface 472 on the noseportion 468 of the arm section 452. Force applied against the camsurface 472 resiliently deflects the arm section 452 away from the basesection 450 from the position shown in solid lines in FIG. 17 to theposition shown in dashed lines. As this occurs, the section 442 of thesuture 440 moves into the recess 460. As the section 442 of the suture440 moves into the recess 460, the arm section 452 springs back to theinitial position shown in solid lines in FIG. 17 to block the entrance446 to the recess 460. This results in the suture section 442 beingretained in the recess 460.

The arm section 454 has the same construction as the arm section 452.Thus, the arm section 454 has a nose or detent portion 476 (FIG. 16)which is engaged by the suture section 444 to deflect the arm section454 as the suture section moves into the recess 462. Once the suturesection 444 has moved into the recess 462, the nose portion 476 on thearm section 454 blocks the entrance to the recess to retain the suturesection 444 in the recess.

The suture 440 and suture retainer 448 are both formed of abiodegradable polymer. It is believed that it may be preferred to formthe suture retainer 448 and suture 440 from an amorphous thermoplastic.The suture 440 and suture retainer 448 may be formed of the samematerial or different materials having similar chemical properties whichare compatible. The suture 440 and suture retainer 448 may be formed ofany of the materials previously mentioned herein or of other materials.

When the suture 440 and suture retainer 448 are to be utilized to securehuman body tissue, the suture 440 is positioned relative to the bodytissue, in a manner similar to that illustrated schematically in FIG. 1.The sections 442 and 444 of the suture 440 are then moved into therecesses 460 and 462 in the suture retainer 448. The nose portions 468and 476 on the arm sections 452 and 454 are effective to retain thesuture sections 442 and 444 in the recesses 460 and 462.

While the suture sections 442 and 444 are tensioned, the suture retainer448 is moved along the suture 440 toward the body tissue. The noseportions 468 and 476 on the arm sections 452 and 454 maintain the suturesections 442 and 444 in the recesses 460 and 462 as the suture retainer448 is moved along the suture 440 toward the body tissue. The sutureretainer 448 is moved into engagement with either the body tissue, inthe manner similar to that illustrated in FIG. 4, or into engagementwith a force distribution member, in the manner similar to thatillustrated in FIG. 5.

While a predetermined tension force is applied to the sections 442 and444 of the suture 440 and while the suture retainer 448 is urged towardthe body tissue with a predetermined force, the suture retainer 448 isbonded to the suture 440. This results in a predetermined tension beingmaintained in the portion of the suture 440 connected with the bodytissue and in the transmission of a predetermined force from the sutureretainer 448 to the body tissue.

To bond the suture 440 to the suture retainer 448, an anvil or supportportion 480 is pressed against the base section 450 of the sutureretainer 448. A horn or acoustic tool 482 is pressed against the armsections 452 and 454 of the suture retainer 448. The arm sections 452and 454 of the suture retainer 448 have protuberances 486 and 488 whichextend toward the horn 482.

The suture retainer 448 is clamped between the anvil 480 and horn 482.The force applied against the arm sections 452 and 454 by the horn 482resiliently deflects the arm sections toward the base section 450 of thesuture retainer 448. This results in the nose portions 468 and 476 onthe arm sections 452 and 454 moving into engagement with the basesection 450. Protuberances 486 and 488 on the arm sections 452 and 454enable the horn 482 to deflect the arm sections through a sufficientdistance to enable the arm sections to engage the base section 450.

Once the suture retainer 448 has been securely clamped between the anvil480 and horn 482, ultrasonic vibratory energy is transmitted from thehorn 482 to the suture retainer 448. The ultrasonic vibratory energytransmitted from the horn 482 to the suture retainer 448 is at afrequency of between 20 kilohertz and 70 kilohertz. It is believed thatit may be preferred to apply ultrasonic vibratory energy at a frequencyof approximately 70 kilohertz or more to the suture retainer 448.

The ultrasonic vibratory energy transmitted from the horn 482 to thesuture retainer 448 is effective to heat the material of the sutureretainer. The heat tends to be concentrated at the joints between thearm sections 452 and 454 and the base section 450. In addition, the heattends to be concentrated at the joints between the suture sections 442and 444 and the suture retainer 448.

The material of the suture retainer 448 is heated into a transitiontemperature range for the material. As the material of the sutureretainer 448 is heated into the transition temperature range, thematerial of the suture retainer softens and becomes pliable. However,the material of the suture retainer 448 does not melt and become aliquid.

The heat softened material of the suture retainer 448 is plasticallydeformed by the force applied against the suture retainer by the anvil480 and horn 482. As the material of the suture retainer 448 isplastically deformed, the recesses 460 and 462 are collapsed. Thematerial of the suture retainer 448 is firmly pressed against the suture440.

Once the material of the suture retainer 448 adjacent to the sections442 and 444 of the suture and adjacent to the nose portions 468 and 476on the arm sections has been heated into a transition temperature rangeand plastically deformed, the application of ultrasonic vibratory energyis interrupted. Heating the material of the suture retainer 448 into itstransition temperature range causes the material to lose its rigidityand soften. The heat softened material of the suture retainer 448 can bedeformed by the clamping force applied by the anvil 480 and horn 482.

Although the application of ultrasonic vibratory energy to the sutureretainer 448 is interrupted, the suture retainer continues to be clampedbetween the anvil 480 and horn 482. If desired, the clamping forceapplied against the suture retainer 448 by the anvil 480 and horn 482could be increased as the application of ultrasonic vibratory energy tothe suture retainer is interrupted.

As the material of the suture retainer cools, the arm sections 452 and454 of the suture retainer are bonded to the base section 450 of thesuture retainer. In addition, the arm sections 452 and 454, connectorsection 456 and base section 450 of the suture retainer 448 are bondedto the sections 442 and 444 of the suture 440. This results in thesuture 440 and the suture retainer 448 being securely interconnected.

In the foregoing description, the suture retainer 448 has been heatedunder the influence of ultrasonic vibratory energy transmitted from thehorn 482 to the suture retainer. It is contemplated that the sutureretainer 448 could also be heated by the direct application of thermalenergy to the suture retainer. For example, a heating element could beprovided in the anvil 480 and/or the horn 482 to function as a heatsource. Alternatively, a heating element could be moved into contactwith the suture retainer 448.

The anvil 480 and horn 482 do not engage the suture 440. The anvil 480and horn 482 engage only the suture retainer 448. This preventsexcessive heating and deformation of the suture 440. There is nosignificant deformation of the suture 440 so that it maintains itsstrength.

Embodiment of FIGS. 18-20

In the embodiment of the invention illustrated in FIGS. 16 and 17, thesections 442 and 444 of the suture 440 are positioned in a pair ofrecesses 460 and 462 in the suture retainer 448. In the embodiment ofthe invention illustrated in FIGS. 18-20, a single section of a sutureis positioned in a single recess in a suture retainer. Since the sutureretainer of the embodiment of the invention illustrated in FIGS. 18-20is generally similar to the suture retainers of the embodiments of theinvention illustrated in FIGS. 1-17, similar terminology will beutilized to identify similar components. It should be understood thatone or more of the features of the other embodiments of the inventiondisclosed herein could be utilized in association with the embodiment ofthe invention illustrated in FIGS. 18-20.

A tissue securing system 489 (FIG. 18) is used in a sterile, operatingroom environment and includes a suture 490 and a suture retainer 496.The suture 490 (FIG. 18) has a section 492 which is connected with humanbody tissue in a manner generally similar to the manner illustratedschematically in FIG. 4. The suture section 492 may be connected with asuture anchor disposed in engagement with one side of a layer of bodytissue. Alternatively, the suture section 492 may be connected with asuture anchor which is embedded in body tissue. The suture 490 could beconnected with a suture anchor having a construction generally similarto the construction of the suture anchors disclosed in U.S. Pat. Nos.5,584,862; 5,549,631; and/or 5,527,343.

A one-piece suture retainer 496 includes main sections 498 and 500. Themain sections 498 and 500 of the suture retainer 496 are interconnectedby a hinge section 502. The suture retainer 496 is formed separatelyfrom the suture 490.

The main sections 498 and 500 and hinge section 502 of the sutureretainer 496 are integrally formed as one piece. The suture 490 andsuture retainer 496 are both formed of a biodegradable polymer. It isbelieved that it may be preferred to form the suture 490 and sutureretainer 496 from the same amorphous thermoplastic material. However,the suture 490 and suture retainer 496 may be formed of differentamorphous thermoplastic materials having similar chemical properties.The suture 490 and suture retainer 496 may be formed from any of thematerials previously mentioned herein or other materials.

The main sections 498 and 500 of the suture retainer 496 are initiallyskewed at an angle of approximately 30° to each other. The main sections498 and 500 cooperate with the hinge section 502 to define a generallyV-shaped recess 506 (FIG. 19) in which the section 492 of the suture isreceived. If desired, the recess 506 could have a configuration which isdifferent than the illustrated V-shaped configuration.

While a predetermined tension is maintained in the suture 490, thesuture retainer 496 is moved along the suture into engagement with thebody tissue, in a manner generally similar to the manner illustrated inFIG. 4 or into engagement with a force distribution member, in themanner generally similar to the manner illustrated in FIG. 5. While apredetermined force is being transmitted from the suture retainer 496 tothe body tissue and while the suture 490 is being tensioned with apredetermined force, the suture 490 is bonded to the suture retainer 496and the main sections 498 and 500 of the suture retainer 496 are bondedtogether.

To effect bonding between the suture retainer 496 and the suture 490, ananvil 512 (FIG. 20) is moved into engagement with the main section 498of the suture retainer 496. At the same time, a horn or acoustic tool514 is moved into engagement with the main section 500 of the sutureretainer 496. The anvil 512 and horn 514 apply force against the sutureretainer 496 to clamp the suture retainer against the suture 490.

As the anvil 512 and horn 514 are clamped against the suture retainer496, the main sections 498 and 500 of the suture retainer are deflectedfrom the linear configuration illustrated in FIG. 19 to the bentconfiguration illustrated in FIG. 20. The anvil 512 and horn 514 have aconfiguration which corresponds to the desired configuration of thesuture retainer 496 when the suture retainer is clamped against thesuture 490 by the anvil and horn.

The suture retainer 496 is heated to effect a bonding between the mainsections 498 and 500 of the suture retainer and to effect a bondingbetween the suture 490 and the main sections 498 and 500 and the hingesection 502 of the suture retainer. To effect this bonding, ultrasonicvibratory energy is transmitted from the horn 514 to the suture retainer496. The ultrasonic vibratory energy transmitted from the horn 514 tothe suture retainer 496 has a frequency of between 20 kilohertz and 70kilohertz. It is believed that it may be preferred to transmitultrasonic vibratory energy having a frequency of 70 kilohertz or morefrom the horn 514 to the suture retainer 496.

The ultrasonic vibratory energy transmitted from the horn 514 to thesuture retainer 496 heats the material of the suture retainer. The heattends to be concentrated at the joints between the main section 498 and500 of the suture retainer and at the joints between the suture 490 andthe main sections 498 and 500 and the hinge section 502 of the sutureretainer. The material of the suture retainer 496 is heated into atransition temperature range for the material.

When the material adjacent to the main sections 498 and 500 of thesuture retainer 496 and adjacent to the joint between the suture 490 andthe suture retainer 496 has been heated into a transition temperaturerange, the application of ultrasonic vibratory energy to the sutureretainer 496 is interrupted. Although the application of ultrasonicvibratory energy from the horn 514 to the suture retainer 496 isinterrupted, the suture retainer continues to be clamped between theanvil 512 and the horn 514. If desired, the force applied against thesuture retainer 496 by the anvil 512 and horn 514 could be increasedsimultaneously with interruption of ultrasonic vibratory energy to thesuture retainer 496.

As the material of the suture retainer 496 is heated into its transitiontemperature range, the material softens and loses its rigidity. Althoughthe material of the suture retainer 496 softens as the material isheated into its transition temperature range, the material does not meltand become liquid. As the material of the suture retainer 496 softens,the force applied against the suture retainer 496 by the anvil 512 andhorn 514 plastically deforms the suture retainer from the configurationillustrated in FIG. 19 to the configuration illustrated in FIG. 20.

As the material of the suture retainer 496 cools, a bond is formedbetween the main sections 498 and 500 of the suture retainer. Inaddition, the main sections 498 and 500 and the hinge section 502 of thesuture retainer 496 are bonded to the suture 490. This results in thesuture retainer 496 having a firm grip on the suture 490. The firm gripof the suture retainer 496 on the suture 490 enables a predeterminedtension force to be transmitted through the suture 490 to the bodytissue and enables a predetermined force to be transmitted from thesuture retainer 496 to the body tissue.

The anvil 512 and horn 514 do not engage the suture 490. The anvil 512and horn 514 engage only the suture retainer 496. This preventsexcessive heating and deformation of the suture 490. The suture retainer496 is bonded to the suture 490 without significant deformation of thesuture.

In the embodiment of the invention illustrated in FIGS. 18-20, a singlesection 492 of the suture 490 is engaged by the suture retainer 496.However, a plurality of sections of suture could be gripped by thesuture retainer 496. Thus, a pair of suture sections, corresponding tothe suture sections 182 and 184 of FIG. 5, could be positioned in therecess 506 (FIG. 19) in the suture retainer 496 and gripped by thesuture retainer. If desired, a force distribution member correspondingto the force distribution member 194 of FIG. 5 could be provided betweenthe suture retainer 496 and the body tissue.

Embodiment of FIG. 21

In the embodiment of the invention illustrated in FIGS. 18-20, thesuture retainer 496 includes a pair of main sections 498 and 500 whichare interconnected by a flexible hinge section 502 and which define arecess 506 in which the suture 490 is received. In the embodiment of theinvention illustrated in FIG. 21, one section of a suture retainercooperates with another section of the suture retainer to define arecess in which a suture is received. Since the embodiment of theinvention illustrated in FIG. 21 is generally similar to the embodimentof the invention illustrated in FIGS. 1-20, similar terminology will beutilized to identify similar components. It should be understood thatone or more of the features of the other embodiments of the inventionillustrated herein could be used with the embodiment of the inventionillustrated in FIG. 21.

A tissue securing system 518 is used in a sterile, operating roomenvironment and includes a suture 520 and a suture retainer 528. Thesuture 520 (FIG. 21) includes a section 522 which is connected with bodytissue. The section 522 of the suture 520 may be connected with bodytissue in the manner illustrated schematically in FIG. 4. However, itshould be understood that the suture 520 could be connected with bodytissue in a different manner if desired.

The suture retainer 528 is formed separately from the suture 520 andencloses a portion of the suture. The suture retainer 528 has arectangular configuration and includes a base section 530 and an armsection 532. The base and arm sections 530 and 532 of the sutureretainer 528 are integrally formed as one piece. The arm section 532cooperates with the base section 530 to define a generally U-shapedrecess 534 in which the suture 520 is received.

The suture retainer 528 may have a configuration which is different thanthe configuration illustrated in FIG. 21. For example, the sutureretainer 528 could have an ovoidal configuration rather than theillustrated rectangular configuration. Although the base section 530 hasbeen illustrated as being substantially wider than the arm section 532,the base and arm sections could be of approximately the same width ifdesired. The base and arm sections 530 and 532 could have configurationsimilar to the configuration of the base section 450 and arm section 452of FIG. 16 if desired. If desired, the recess 534 could have a differentconfiguration. For example, the recess 534 could have a configurationsimilar to the configuration of the recess 460 of FIG. 16.

The suture retainer 528 may be formed of any one of many differentmaterials, including any of the materials previously mentioned herein.It may be preferred to form the suture retainer 528 of a biodegradablematerial. The suture 520 may be formed of the same biodegradablematerial as the suture retainer 528. It is believed that it may bepreferred to form both the suture 520 and suture retainer 528 of anamorphous polymer, such as polyhydroxyalkanoate. Of course, the suture520 and suture retainer may be formed of other materials if desired.

When the suture 520 and suture retainer 528 are to be utilized to securebody tissue, the suture 520 is positioned relative to body tissue byengagement with a suture anchor or other device. The suture 520 is thenpositioned in the recess 534 in the suture retainer 528. The suture 520may be positioned in the recess 534 by moving the suture through anentrance to the recess. Alternatively, the suture retainer 528 could bemoved relative to the suture.

Once the suture 520 has been positioned in the recess 534, apredetermined tension force is applied to the suture 520. The sutureretainer 528 is moved along the suture toward the body tissue. Thesuture retainer is pressed against the body tissue in the mannerillustrated schematically in FIG. 4 or pressed against a forcedistribution member in the manner illustrated schematically in FIG. 5. Apredetermined force is transmitted from the suture retainer 528 to thebody tissue while the predetermined tension is maintained in the suture520.

To interconnect the suture 520 and suture retainer 528, the sutureretainer is clamped between a horn and anvil of an ultrasonic energyapplication apparatus. Ultrasonic energy is then transmitted from thehorn to the suture retainer 528 in the manner previously described inconjunction with the embodiments of the invention illustrated in FIGS.1-20.

The clamping force applied against the suture retainer 528 by the hornand anvil deflects the arm section 532 of the suture retainer toward thebase section 530 of the suture retainer. The arm section moves intoengagement with the base section 530 of the suture retainer 528 andfirmly grips the suture 520 under the influence of the clamping forceapplied by the anvil and horn.

Ultrasonic energy at a frequency of between 20 kilohertz and 70kilohertz is then applied to the suture retainer 528 by the horn. Theultrasonic vibratory energy heats the material of the suture retainer528 into its transition temperature range. As the material of the sutureretainer 528 is heated into the transition temperature range, thematerial of the suture retainer softens and loses its rigidity. As thisoccurs, the softened material of the suture retainer 528 is plasticallydeformed by the clamping force applied against the suture retainer bythe anvil and horn.

The transmission of ultrasonic vibratory energy to the suture retainer520 is then interrupted. However, the clamping force against the sutureretainer is maintained and may even be increased.

As the material of the suture retainer 528 cools, the suture retainer528 is securely connected to the suture 520. Thus, the arm section 532is bonded to the base section 530 of the suture retainer. Both the basesection 530 and the arm section 532 are bonded to the suture 520. Thisresults in the suture retainer 528 having a firm grip on the suture 520to maintain the tension in the suture and the transmission of force fromthe suture retainer to body tissue.

Embodiment of FIG. 22

In the embodiment of the invention illustrated in FIG. 21, the armsection 532 is generally straight and cooperates with the base section530 to form a recess 534. In the embodiment of the invention illustratedin FIG. 22, the suture retainer has an arcuate arm section whichcooperates with a base section to form a recess which receives a suture.Since the embodiment of the invention illustrated in FIG. 22 isgenerally similar to the embodiments of the invention illustrated inFIGS. 1-21, similar terminology will be utilized to designate similarcomponents. It should be understood that one or more of the features ofthe other embodiments of the invention disclosed herein could beutilized in conjunction with the embodiment of the invention illustratedin FIG. 22.

A suture 540 is connected with body tissue in the manner illustratedschematically in FIG. 4. A suture retainer 542 at least partiallyencloses the suture 540. The suture retainer 542 is integrally formed asone piece which is separate from the suture 540.

The suture retainer 542 includes a base section 544 and an arm section546. The base section 544 and arm section 546 of the suture retainer areintegrally formed as one piece. The suture retainer 542 has the samegenerally rectangular configuration as the suture retainer 528 of FIG.21. However, the suture retainer 542 could have a differentconfiguration if desired.

The suture retainer 542 may be formed of a biodegradable polymericmaterial. It is believed that it may be preferred to form both thesuture 540 and the suture retainer 542 from the same biodegradablepolymeric material. The suture 540 and suture anchor may be formed froman amorphous thermoset polymer. If desired, the suture retainer 542 andsuture 540 could be formed of different polymeric materials which arecompatible with each other. The suture 540 and suture retainer 542 couldbe formed from many different materials, including any of the materialsmentioned herein.

The arm section 546 of the suture retainer 542 cooperates with the basesection 544 of the suture retainer to define a recess 550 which receivesa portion of the suture 540. The arm section 546 has a nose portion 554which partially blocks an entrance 556 to the recess 550. The noseportion 554 on the arm section 546 is effective to retain the suture 540in the recess 550.

When the suture 540 and suture retainer 542 are to be utilized to securebody tissue, the suture 540 is positioned relative to the body tissue ina manner similar to that illustrated in FIG. 4. Of course, the suture540 could be connected with the body tissue in a different manner ifdesired. For example, the suture 540 could be connected with a sutureanchor which is embedded in the body tissue.

Once the suture 540 has been positioned relative to the body tissue, thesuture is tensioned and positioned in the recess 550 in the sutureretainer 542. To position the suture 540 in the recess 550, the suturecan be moved relative to the recess or the recess can be moved relativeto the suture.

As the suture 540 moves into the recess 556, the a cylindrical outerside surface of the suture applies force against a cam surface 558 onthe nose portion 554 of the arm section 546. The force applied againstthe cam surface 558 deflects the arm section 546 outward away from thebase section 544 of the suture retainer 542 to open the entrance 556 tothe recess 550. This enables the suture 540 to move into the recess 550.

After the suture 540 has moved into the recess 550, the arm section 546springs back to its initial position, illustrated in FIG. 22. When thisoccurs, the nose portion 554 on the arm section 546 partially blocks theentrance 556 to the recess 550 to retain the suture 540 in the recess.

Once the suture 540 has been positioned in the recess 550, the suture540 is tensioned with a predetermined force and the suture retainer 542is moved along the suture toward the body tissue. The suture retainer542 is moved into engagement with the body tissue in the mannerillustrated in FIG. 4 or is moved into engagement with a forcedistribution member in the manner illustrated in FIG. 5. A predeterminedforce is transmitted from the suture retainer 542 to the body tissuewhile the predetermined tension is maintained in the suture 540. Thisresults in layers of body tissue being pressed against each other.

The suture retainer 542 and suture 540 are then interconnected tomaintain the predetermined tension in the portion of the suture 540connected with the body tissue and to maintain the transmission of thepredetermined force from the suture retainer to the body tissue. Tointerconnect the suture retainer 542 and suture 540, the suture retaineris clamped between an anvil 562 and a horn 564 of an ultrasonic energyapplication apparatus. The clamping force applied against the sutureretainer 542 by the anvil 562 and horn 564 resiliently deflects the armsection 546 so that the nose portion 554 of the arm section moves intoengagement with the base section 544 of the suture retainer. Inaddition, the arm section 546 is firmly pressed against the suture 540.

While the clamping force is applied to the suture retainer 542 by theanvil 562 and horn 564, ultrasonic vibratory energy is transmitted fromthe horn to the suture retainer. The ultrasonic vibratory energy has afrequency of between 20 kilohertz and 70 kilohertz. It is believed thatit may be preferred to utilize ultrasonic vibratory energy having afrequency of approximately 70 kilohertz or more.

The ultrasonic vibratory energy heats the material of the sutureretainer into its transition range. The heat tends to be concentrated atthe joint between the arm section 546 and the base section 544 of thesuture retainer 542. In addition, the heat is concentrated at the jointbetween the suture 540 and the suture retainer 542.

Once the material of suture retainer 542 has been softened by beingheated into its transition temperature range, the application ofultrasonic vibratory energy to the suture retainer is interrupted. Eventhough the application of ultrasonic vibratory energy to the sutureretainer is interrupted, the clamping force applied against the sutureretainer 542 by the anvil 562 and horn 564 is maintained or evenincreased.

As the material of the suture retainer 542 cools, a secure bond isformed between the arm section 546 and the base section 544 of thesuture retainer. In addition, a secure bond is formed between the suture540 and the base section 544 and arm section 546 of the suture retainer542.

Embodiment of FIG. 23

In the embodiments of the invention illustrated in FIGS. 1-22, varioustypes of suture retainers for use in securing a suture relative to bodytissue have been illustrated. The embodiment of the inventionillustrated in FIG. 23 is not limited to any particular suture retainerconstruction. However, similar terminology will be utilized indescribing the components of the embodiment of the invention illustratedin FIG. 23 as were previously utilized in connection with theembodiments of the invention illustrated in FIGS. 1-22.

In the embodiment of the invention illustrated in FIG. 23, a relativelythick layer of tissue, designated by the numeral 570, is to be connectedwith a relatively thin layer of tissue, designated by the numeral 572. Atissue securing system 574 is utilized to interconnect the thick andthin layers of tissue. The tissue securing system 574 is located aprecise distance from an end 578 of the thick layer 570 of tissue and anend 580 of the thin layer 572 of tissue.

In the illustrated embodiment of the invention, the tissue securingsystem 574 is located the same distance from the end 578 of the thicklayer of tissue as in which the tissue fixation system is located fromthe end 580 of the thin layer of tissue. This results in the two layersof tissue growing together with a minimum of scarring. In addition, thetissue securing system 574 holds the thick layer 570 and the thin layer572 of tissue against shifting relative to each other.

If a staple of loop-type suture was used to interconnect the thick layer570 and thin layer 572 of tissue, a shifting could occur between the twolayers of tissue. This shifting could occur inside of the loop formed bythe suture or the staple. The shifting can result in extensive scarringand could result in a non-uniform repair of the tissue. The obtaining ofa uniform repair of tissue is particularly important wheninterconnecting a conduit, such as a blood vessel, which has beensevered. By using the tissue securing system 574, shifting movement cannot occur between the thick layer 570 and thin layer 572 of tissue. Thisprevents one of the layers from being deflected into the path of flow ofmaterial, such as blood, through the conduit in a manner which restrictsthe conduit and subsequently results in a blockage.

The specific tissue securing system 574 illustrated in FIG. 23 includesa suture anchor 584 which is disposed in engagement with an outer sidesurface of the thin layer 572 of tissue. A suture 586 extends throughboth the thin layer 572 of tissue and the thick layer 570 of tissue. Thesuture 586 is disposed the same distance from the end 578 of the thicklayer 570 of tissue as it is located from the end 580 of the thin layer572 of tissue. A suture retainer 590 is connected with a portion of thesuture 586 opposite from the anchor 584. The suture retainer 590 mayhave any one of the constructions described herein or a differentconstruction.

In accordance with a feature of the present invention, the sutureretainer 590 is connected with the suture 586 by the application ofultrasonic vibratory energy to the suture retainer 590. The applicationof ultrasonic vibratory energy to the suture retainer 590 results in arapid heating of the material of the suture anchor. The very short timewhich is required to heat the material of the suture retainer 590 by theapplication of ultrasonic vibratory energy enables the suture retainerto be heated into its transition temperature range and softened withoutdetrimentally affecting the layers 570 and 572 of body tissue.

Although it is contemplated that the amount of heat which is required toheat material of the suture retainer 590 into the transition temperaturerange by the application of ultrasonic vibratory energy will varydepending upon the construction of the suture retainer 590, anultrasonic vibratory energy application time of between 0.25 seconds and1.0 seconds is required to connect any one of the suture retainers ofFIGS. 1-22 with a suture. After the suture retainer 590 has been heatedand the application of ultrasonic vibratory energy interrupted, thesuture retainer is allowed to cool for approximately one second. Sincethe suture retainer 590 is heated into its transition temperature rangefor an extremely short period of time, the suture retainer can be heatedto relatively high temperatures which would be detrimental to the layers570 and 572 of the body tissue if the application of ultrasonicvibratory energy was maintained over an extended period of time.

In the embodiments of the invention illustrated in FIGS. 1, 4 and 23,the tissue securing systems are being utilized to interconnect layers ofsoft tissue disposed in juxtaposition with each other. However, itcontemplated that the tissue securing system could be utilized tointerconnect body tissues having different characteristics. For example,the tissue securing system could be utilized to connect soft tissue,such as a tendon, or ligament, with bone. If the tissue securing systemwas utilized to connect soft tissue with bone, the suture anchor wouldengage the bone in a manner similar to that disclosed in U.S. Pat. Nos.5,403,348 and/or 5,534,012. The suture would then extend from the anchorpositioned in the bone into engagement with the soft body tissue. Thesuture could be wrapped around the soft body tissue or, alternatively,could extend through the soft body tissue. A suture retainer having anyof the constructions illustrated in FIGS. 1-22 could be connected withone or two sections of the suture to hold the soft body tissue in placerelative to the bone.

Although it is preferred to connect the suture retainers illustrated inFIGS. 1-22 with a suture, the suture retainers could be connected withother force transmitting members or directly with body tissue ifdesired. For example, any one of the suture retainers of FIGS. 1-22could be connected with a K-wire or a rigid force transmitting membersuch as a rod or externally threaded stud. Alternatively, the sutureretainer could be connected directly to body tissue, such as a ligamentor tendon.

In the embodiments of the invention illustrated in FIGS. 1-22, thesuture retainers have been connected with sutures formed of polymericmaterial. However, the sutures could be formed of metal if desired.Thus, the suture retainers illustrated in FIGS. 1-22 could be connectedwith any desired type of member which transmits force, including bodytissue.

It is contemplated that the suture retainers illustrated in FIGS. 1-22will be utilized in an operating room environment. The suture retainersmay be positioned within and fully enclosed by a patient's body.Alternatively, the suture retainers may be partially disposed outside ofthe patient's body.

Embodiment of FIG. 24

It is contemplated that the suture retainers of FIGS. 1-23 may be heatedby the application of ultrasonic vibratory energy. The ultrasonicvibratory energy may be applied in many different ways. One knownapparatus for applying the ultrasonic vibratory energy to any one of thesuture retainers of FIGS. 1-23 is illustrated schematically in FIG. 24.

An ultrasonic vibratory energy application apparatus 600 includes a pairof members 602 and 604 which are interconnected at a pivot connection606. An anvil or support member 610 is mounted on one end portion of themember 602. A horn or ultrasonic energy application member 612 ismounted on one end portion of the member 604.

Sections 614 and 616 of a suture retainer are disposed in engagementwith the anvil 610 and horn 612. The sections 614 and 616 of the sutureretainer may have the same construction as the sections 222 and 224 ofthe suture retainer 220 of FIG. 6. When handle end portions 620 and 622of the members 602 and 604 are moved together, the anvils 610 and horn612 press the sections 614 and 616 of the suture retainer againstsections 626 and 628 of a suture.

A generator 630 is connected with a standard electrical power supply(120-240 volts). The generator 630 converts the standard electricalpower supply from 50/60 hertz to an ultrasonic frequency, that is afrequency greater than 20 kilohertz. The high frequency electricalenergy is conducted through a cable 632 to the member 604.

Suitable electrically insulated conductors in the member 604 conduct thehigh frequency electrical energy through a transducer (not shown)connected with the horn. The transducer changes the electrical energyinto low amplitude mechanical vibrations. These vibrations may betransmitted to a booster to increase or decrease the amplitude of thevibrations. The vibrations are then transmitted to the horn 612 whichapplies them to the sections 614 and 616 of the suture retainer.

Embodiment of FIG. 25

In the embodiment of the invention illustrated in FIG. 25, the horn andanvil are disposed on a pair of members 602 and 604 which are pivotallyinterconnected. In the embodiment of the invention illustrated in FIG.25, the horn and anvil of an ultrasonic energy application apparatus aremovable relative to each other along a linear path.

The ultrasonic energy application apparatus 640 of FIG. 25 includes ahandle 642. A horn 644 is connected with the handle 642. An anvil 646 isintegrally formed as one piece with a member 648 which is movable alonga linear path relative to the handle 642. An actuator member 650 isconnected with the member 648 and is movable toward the left (as viewedin FIG. 25) to move the anvil 646 toward the horn 644.

Sections 660 and 662 of a suture are disposed between the sections 656and 658 of the suture retainer. The suture retainer may have aconstruction similar to the construction of the suture retainerillustrated in FIG. 6.

A generator 666 is connected with the handle 642 by a cable 668. Thecable 668 connects the generator 666 with a transducer which changeshigh frequency electrical energy conducted from the generator 666 to lowamplitude mechanical vibration. These vibrations are transmitted to abooster. The vibrations are then transmitted to the horn. The hornapplies the vibrations to the sections 658 of the suture retainer.

It should be understood that the ultrasonic energy application apparatusof FIGS. 24 and 25 could have any desired construction. It iscontemplated that ultrasonic energy application apparatus which iscommercially available from Dukane Corporation may be utilized. Ofcourse, ultrasonic energy application apparatus which is commerciallyavailable from other sources may be used if desired. It should beunderstood that the suture retainers of FIGS. 1-23 may be utilized inassociation with any desired ultrasonic energy application apparatus.

Embodiment of FIGS. 26-28

In the embodiments of the invention illustrated in FIGS. 1-22, a sutureretainer has been utilized to interconnect sections of a suture. In theembodiment of the invention illustrated in FIGS. 26 through 28, thesections of the suture are directly connected to each other. Since theembodiment of the invention illustrated in FIGS. 26-28 is generallysimilar to the embodiments of the invention illustrated in FIGS. 1-22,similar terminology will be utilized to identify similar components. Itshould be understood that one or more of the features of otherembodiments of the invention illustrated herein could be used with theembodiment of the invention illustrated in FIGS. 26-28.

A tissue securing system 680 (FIG. 26) includes a suture 682. The suture682 includes left and right sections 684 and 686 which areinterconnected without using a suture retainer. The two sections 684 and686 may be knotted together and then interconnected. Alternatively, thetwo suture sections may just be interconnected, without knotting in themanner illustrated in FIGS. 27 and 28.

The tissue securing system 680 secures upper and lower layers 690 and692 of soft, human body tissue in linear apposition with each other.Thus, the two layers 690 and 692 of human body tissue are approximatedand held against movement relative to each other by a suture 682.Although the two layers 690 and 692 of human body tissue have beenschematically illustrated in FIG. 26 as being spaced apart from eachother, they are held in a side-by-side relationship with each other andpressed together by tightening the tissue securing system 680. Pressingthe two layers 690 and 692 together with the tissue securing system 680promotes healing of the tissue.

Although the tissue securing system 680 has been illustrated in FIG. 26as being used to hold layers of soft tissue in linear apposition witheach other, it is contemplated that the tissue securing system may beused in many different locations in a patient's body to secure tissue.For example, the tissue securing system 680 could be utilized to securesoft tissue such as a ligament or tendon against movement relative to abone. Alternatively, the tissue securing system 680 could be utilized tointerconnect portions of a flexible conduit, such as a blood vessel orintestine. It should be understood that the tissue securing system 680may be used with either hard body tissue or soft body tissue or bothhard and soft body tissue.

A force distribution member 694 is disposed between the two sections 684and 686 of the suture 682. When the suture 682 is tensioned, the forcedistribution member 694 distributes the force over a relatively largearea of the upper layer 690 of body tissue. Although only the forcedistribution member 694 is illustrated in FIG. 26 in association withthe upper layer 690 of body tissue, a similar force distribution membercould be provided in association with the lower layer 692 of body tissueif desired.

In accordance with a feature of this embodiment of the invention, thesections 684 and 686 of the suture 682 are interconnected without usinga suture retainer similar to the suture retainers illustrated in FIGS.1-22 herein. In the embodiment of the invention illustrated in FIGS.26-28, the two sections 684 and 686 of the suture 682 are heated,flattened, and bonded together. Heating the suture sections 684 and 686softens the material of the suture sections and allow them to beplastically deformed from a cylindrical configuration to a flat,generally planar configuration. Flattening the cylindrical sections 684and 686 of the suture 682 increases the area at which the suturesections can be interconnected and thereby increases the strength of theconnection between the suture sections.

The suture 682 may be formed of many different materials, including thematerials previously mentioned herein. The suture 682 may be formed ofeither a biodegradable or a non-biodegradable material. It is believedthat it will be preferred to form the suture 682 of a biodegradablematerial. It may be preferred to form the suture 682 of a biodegradableamorphous polymer. For example, the suture 682 could be formed ofpolyhydroxyalkanoate. Of course, the suture 682 could be formed of othermaterials if desired.

When the suture 682 is to be connected with the layers 690 and 692 ofbody tissue, the suture is positioned as illustrated schematically inFIG. 26. The sections 684 and 686 of the suture 682 are tensioned with apredetermined force. While the sections 684 and 686 of the suture arebeing tensioned, the force distribution member 694 is pressed againstthe upper layer 690 of body tissue. This results in the upper and lowerlayers 690 and 692 of the body tissue being compressed together with apredetermined force.

Once the layers 690 and 692 have been pressed together with apredetermined force by tensioning the sections 684 and 686 of the suture682 and pressing the force distribution member 694 against the bodytissue, the sections of the suture are interconnected. To interconnectthe sections 684 and 686 of the suture 682, the two sections are pulledtight across the force distribution member and disposed in anoverlapping relationship. An anvil 700 is positioned on one side of thetwo sections 684 and 686 of the suture 682. A horn 702 is positioned onthe opposite side of the sections 684 and 686 of the suture 682. Theanvil 700 and horn 702 are pressed against the opposite sides of thesuture 682 with a predetermined force.

The suture sections 684 and 686 are stacked in a side-by-siderelationship between the anvil 700 and horn 702. The anvil 700 engagesone suture section and the horn 702 engages the other suture section.Thus, the anvil 700 may engage the suture section 684 and the horn 702my engage the suture section 686.

While the sections 684 and 686 of the suture 682 are clamped between theanvil 700 and horn 702, ultrasonic vibratory energy is transmitted fromthe horn 702 to the sections 684 and 686 of the suture. At this time,the suture sections are tensioned with a predetermined force. Theultrasonic vibratory energy is at a frequency of between 20 kilohertzand 70 kilohertz. It is believed that it may be preferred to transmitultrasonic vibratory energy to the sections of the suture 682 at afrequency of 70 kilohertz or more.

The ultrasonic vibratory energy transmitted from the horn 702 to thesuture 682 is effective to heat the material of the suture into itstransition temperature range. As the material of the suture 682 isheated into its transition temperature range, the material loses itsrigidity and softens. However, the material of the suture 682 does notmelt and become a liquid as it is heated into the transition temperaturerange.

The heated and softened material of the sections 684 and 686 of thesuture 682 are flattened from the cylindrical configuration of FIG. 27to form thin layers which are disposed in a side-by-side relationshipand have a generally plate-like configuration which is illustratedschematically in FIG. 28. Thus, the section 684 of the suture isflattened to form a layer 706 having an upper major side surface 708which extends parallel to a lower major side surface 710 of the layer706. Similarly, the section 686 of the suture 682 is flattened to form alayer 714 having a flat upper major side surface 716 which extendsparallel to a lower major side surface 718 of the layer 714.

As the section 684 of the suture 682 is flattened, it is extendedsideways in opposite directions along a path which extends perpendicularto a central axis 722 (FIG. 28) of the suture section 684. Similarly, asthe section 686 of the suture 682 is flattened, it is extended sidewaysin opposite directions along a path which extends perpendicular to acentral axis 724 of the suture section 686. Although the flattenedsuture sections 684 and 686 have been illustrated as having planar majorside surfaces 708, 710, 716 and 718, the suture sections could beflattened in such a manner as to have arcuately curving major sidesurfaces. For example, the major side surfaces 708, 710, 716 and 718 ofthe flattened suture sections 684 and 686 could curve upward (as viewedin FIG. 27) away from the body tissue 690.

The side surfaces 708, 710, 716 and 718 all have a relatively largearea. The area of each unit of length as measured along a longitudinalcentral axes 722 and 724 of the suture sections at the side surfaces708, 710, 716 and 718, is greater than the corresponding area of a unitof length of the section of the suture having the cylindricalconfiguration illustrated in FIG. 27.

Thus, a one-inch length of a cylindrical portion of the suture 682 has acircumferential area of pi (3.1416) times the diameter of thecylindrical section 684 of the suture 682. A one inch length, asmeasured along a longitudinal central axis 722 of the suture section684, of the upper side surface 708 of the layer 706 has an area which isgreater than pi (3.1416) times the diameter of the cylindrical portionof the suture 682. Similarly, a unit of length of the upper major sidesurface 716 of the layer 714 is greater than the area of a unit oflength of the cylindrical portion of the suture 682.

When the sections 684 and 686 of the suture 682 have been heated andflattened from the cylindrical configuration of FIG. 27 to theplastically deformed and flattened configuration of FIG. 28 by the anvil700 and horn 702, the application of ultrasonic vibratory energy to thelayers 706 and 708 by the horn 702 is interrupted. As the material ofthe layers 706 and 714 cools, a secure bond is formed between the layers706 and 714 throughout the extent of the lower major side surface 710 ofthe upper layer 706 and the upper major side surface 716 of the lowerlayer 714. The relatively large area of the bond between the two layers706 and 714 provides a strong interconnection between the two suturesections 684 and 686.

In the foregoing description, the sections 684 and 686 were heated,under the influence of ultrasonic vibratory energy transmitted from thehorn 702, and flattened to have surface areas which are greater than thesurface area of a corresponding length of a cylindrical portion of thesuture 682. However, it is contemplated that the sections 684 and 686 ofthe suture 682 could be flattened to a lesser extent. If this was done,the area of one of the major side surfaces, for example the lower majorside surface 710 of the layer 706, might not be as great as the area ofa corresponding length of a cylindrical portion of the suture 682. Thus,the sections 684 and 686 of the suture 682 may be flattened and extendedsideways to a greater or lesser extent. Even a relatively small extentof flattening of the sections 684 and 686 of the suture 682 will resultin an increase in the area at which the two sections of the suture arebonded together. This is because the circumferential extent of a bondformed between a pair of cylindrical surfaces disposed in tangentialengagement is relatively small. The extent of the bond between thesurfaces 710 and 716 is relatively large even though the surfaces have asmaller extent than illustrated in FIG. 28.

What is claimed is:
 1. A method of linear securement of body tissue, themethod comprising: implanting at least a portion of a suture in twolayers of body tissue in a single linear line, such that the two layersof body tissue are disposed in linear apposition, and the two layers ofbody tissue are comprised of a first layer and a second layer;implanting a suture anchor in or adjacent to the first layer of bodytissue, wherein the suture anchor is coupled to a first end of thesuture; positioning a portion of a fastener over the suture; coupling asecond end of the suture to a force application assembly, wherein theforce application assembly is configured to indicate the tension forceapplied to the suture, and wherein the force application assembly iscomprised of at least one of a transducer and a load cell to provide anoutput signal to indicate the tension force applied to the suture;applying a predetermined tension force on the suture with the forceapplication assembly coupled to the second end of the suture, whereinthe predetermined tension force is dependent on at least one of the sizeand material of the suture; sliding the fastener along the suture towardthe second layer of body tissue, wherein the fastener is influencedalong the suture with a force application member, the force applicationmember having an opening and a passage for the suture extending throughat least a portion of the force application member, and the forceapplication member configured to at least one of contact and apply forceto the fastener; applying a first predetermined axial compressive forceto the fastener with the force application member; and fixedly couplingthe fastener to the suture by applying ultrasonic vibratory energy and asecond predetermined compression force by a horn that directly contactsthe fastener.
 2. The method of claim 1, wherein applying the secondcompressive force further comprises applying a compressive force for apredetermined amount of time.
 3. The method of claim 2, wherein thesecond compressive force is applied for about 1.0 second afterinterruption of the ultrasonic vibratory energy.
 4. The method of claim1, wherein positioning a portion of a fastener further comprisespositioning a portion of a fastener including a polymer.
 5. The methodof claim 4, wherein positioning a portion of a fastener including apolymer further comprises positioning a portion of a fastener includingat least one of a biodegradable polymer and an amorphous thermoplasticmaterial.
 6. The method of claim 4, wherein positioning a portion of afastener including a polymer further comprises positioning a portion ofa fastener including a polymer that has an amorphous component.
 7. Themethod of claim 1, wherein implanting at least a portion of a suturefurther comprises implanting at least a portion of suture that is atleast one of a monofilament and formed from a plurality ofinterconnected filaments.
 8. The method of claim 1, wherein positioninga portion of a fastener further comprises positioning a portion of afastener including a first material and a second material.
 9. The methodof claim 1, wherein fixedly coupling the fastener to the suture furthercomprises applying heat to the fastener together with the ultrasonicvibratory energy.
 10. The method of claim 1, wherein implanting at leasta portion of a suture in two layers of body tissue further comprisesimplanting at least a portion of a suture in two layers of body tissueincluding at least one of hard body tissue, soft body tissue, bloodvessel, intestine, and conduit.
 11. A method of linear securement ofbody tissue, the method comprising: implanting at least a portion of anobject in two layers of body tissue in a single linear line, such thatthe two layers of body tissue are disposed in linear apposition, and thetwo layers of body tissue are comprised of a first layer and a secondlayer; implanting an anchor in or adjacent to the first layer of bodytissue, wherein the anchor is coupled to the object; positioning atleast a portion of a fastener over the object; coupling the object to aforce application assembly, wherein the force application assembly isconfigured to indicate the force applied to the object, and wherein theforce application assembly is comprised of at least one of a transducerand a load cell to provide an output signal to indicate the forceapplied to the object; sliding the fastener along the object toward thesecond layer of body tissue, wherein the fastener is influenced alongthe object with a force application member, the force application memberhaving an opening for the object extending through at least a portion ofthe force application member, and the force application memberconfigured to at least one of contact and apply force to the fastener;applying a first predetermined axial compressive force to the fastenerwith the force application member; fixedly coupling the fastener to theobject by applying ultrasonic vibratory energy to the fastener by atleast a portion of a horn that directly contacts the fastener; andapplying a second predetermined compressive force to the fastener, by atleast a portion of the horn that directly contacts the fastener, whilefixedly coupling the fastener to the object to secure the body tissue.12. The method of claim 11, wherein applying ultrasonic vibratory energyto the fastener by at least a portion of a horn further comprisesapplying ultrasonic vibratory energy to the fastener by at least aportion of a horn having at least one of a frustoconical and cylindricalconfiguration.
 13. The method of claim 11, wherein implanting at least aportion of an object comprises implanting at least a portion of anobject that includes a metallic material.
 14. The method of claim 11,wherein implanting at least a portion of an object comprises implantingat least a portion of an object that is at least one of a rigid implant,K-wire, rod, and externally threaded stud.
 15. The method of claim 11,wherein implanting at least a portion of an object in two layers of bodytissue further comprises implanting at least a portion of an object intwo layers of body tissue including at least one of hard body tissue,soft body tissue, blood vessel, intestine, and conduit.
 16. A method oflinear securement of body tissue with a fastener, the method comprising:implanting at least a portion of an object in two layers of body tissuein a single linear line, such that the two layers of body tissue aredisposed in linear apposition; positioning at least a portion of afastener proximate the object; coupling the object to a forceapplication assembly, wherein the force application assembly isconfigured to indicate the force applied to the object, and wherein theforce application assembly is comprised of at least one of a transducerand a load cell to provide an output signal to indicate the forceapplied to the object; sliding the fastener along the object toward theupper layer of body tissue, wherein the fastener is influenced along theobject with a force application member, the force application memberhaving an opening for the object extending through at least a portion ofthe force application member, and the force application memberconfigured to at least one of contact and apply force to the fastener;applying a first predetermined axial compressive force to the fastenerwith the force application member; and fixedly coupling the fastener tothe object by applying ultrasonic vibratory energy and a secondpredetermined compression force by a horn that directly contacts thefastener.
 17. The method of claim 16, wherein fixedly coupling thefastener to the object further comprises applying ultrasonic vibratoryenergy to the fastener for a period of time between 0.25 and 1.0seconds.
 18. The method of claim 16, wherein implanting at least aportion of an object in two layers of body tissue further comprisesimplanting at least a portion of an object in two layers of body tissueincluding at least one of hard body tissue, soft body tissue, bloodvessel, intestine, and conduit.